Pivotal results from TRIUMPH-2 showed retatrutide, an investigational triple hormone receptor agonist, delivered substantial weight loss and A1C improvements in obesity and type 2 diabetes
Findings from ACHIEVE-4, the largest and longest study of Foundayo in type 2 diabetes, reaffirmed its safety profile and suggested the potential to provide cardiovascular benefits
Lilly will unveil Phase 2 data for eloraTZP, our latest triple-acting medicine combining the selective amylin receptor agonist eloralintide and GIP/GLP-1 receptor agonist tirzepatide
INDIANAPOLIS, Sept. 15, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), Mounjaro (tirzepatide) and Foundayo (orforglipron), will present new data across its cardiometabolic health portfolio at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) taking place September 28 to October 2, 2026 in Milan, Italy. These data, spanning multiple mechanisms and modalities, reflect Lilly's commitment to changing the course of cardiometabolic disease by expanding treatment choice today and raising the standard of care for tomorrow.
"More than a billion people worldwide are living with diabetes or obesity, and meeting their diverse needs requires multiple treatment options based on different mechanisms," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "We've built our portfolio with a goal of changing the course of the diabetes and obesity epidemics. At EASD 2026, we're showing what the next generation of innovation could deliver for patients, and how we intend to raise the bar for medicines of the future."
Lilly will also host an industry symposium, Changing the Course of Cardiometabolic Disease, on Monday, September 28 from 10:00 a.m. to 4:00 p.m. CEST, chaired by Prof. Rachel Batterham, senior vice president, medical innovation and external engagement, Lilly Cardiometabolic Health. Marking 150 years of Lilly innovation, the program will explore how obesity and type 2 diabetes can be treated from early stages of disease, with sessions on the emerging role of oral therapies and the next generation of mechanisms with the potential to redefine patient care.
Select Lilly Presentations at EASD 2026
Retatrutide symposium | Wednesday, September 30, 2026 | 8:30 to 9:30 a.m. CEST
This EASD-sponsored symposium will present Phase 3 results for retatrutide, an investigational once-weekly GIP, GLP-1, and glucagon triple receptor agonist.
TRIUMPH-2: Adults with obesity or overweight and type 2 diabetes taking retatrutide lost up to an average of 49.6 lbs (22.5 kg; 20.8%) and lowered their A1C by up to an average of 1.6% at 80 weeks.1
Mounjaro (tirzepatide) symposium | Wednesday, September 30, 2026 | 8:30 to 9:30 a.m. CEST
This EASD-sponsored symposium will present results for Mounjaro (tirzepatide) in adults living with type 2 diabetes and established cardiovascular disease.
SURPASS-CVOT
: Mounjaro demonstrated non-inferiority vs. Trulicity with an 8% lower risk of MACE-3 events (HR: 0.92; 95.3% CI: 0.83 to 1.01), while delivering greater reductions in A1C and weight in adults with type 2 diabetes and established cardiovascular disease.2,3
EloraTZP symposium | Wednesday, September 30, 2026 | 4:30 to 5:30 p.m. CEST
This EASD-sponsored symposium on amylins in diabetes will feature Phase 2 results for eloraTZP, an investigational combination of eloralintide and tirzepatide, in adults with obesity or overweight and type 2 diabetes.
Foundayo (orforglipron) symposium | Thursday, October 1, 2026 | 8:30 to 9:15 a.m. CEST
This EASD-sponsored symposium will present Phase 3 results for Foundayo (orforglipron) across the ACHIEVE type 2 diabetes program.
ACHIEVE-4: Foundayo demonstrated non-inferiority versus insulin glargine, with a 16% lower risk of MACE-4 events (HR: 0.84; 95.0% CI: 0.59 to 1.20) and a 23% lower risk of MACE-3 events (HR: 0.77 95.0% CI: 0.52 to 1.13), in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk.2
Foundayo (orforglipron) Oral Presentations and Posters
ACHIEVE-2/ACHIEVE-3 Time-to-Goal Analysis: Foundayo 17.2 mg helped adults with type 2 diabetes reach their A1C target and body weight loss goals faster than dapagliflozin and oral semaglutide 7 mg and 14 mg.4
ATTAIN-1 Physical and Psychosocial Functioning: In adults with obesity or overweight and at least one weight-related medical problem, Foundayo improved both physical and psychosocial functioning versus placebo.
Zepbound and Mounjaro (tirzepatide) Oral Presentations and Posters
SURMOUNT-5 Exploratory Proteomic Findings: Zepbound 10 mg and 15 mg were associated with distinct changes in the plasma proteome compared with semaglutide 1.7 mg and 2.4 mg, offering early biological insight into the differences in cardiometabolic benefit observed between the two therapies in the head-to-head SURMOUNT-5 trial.
SURPASS-EARLY Pre-Specified Analysis: Mounjaro improved markers of beta cell function and insulin sensitivity in early type 2 diabetes.
Phase 4 T-RAM: Mounjaro helped adults with type 2 diabetes maintain glycemic control and was generally well-tolerated during Ramadan fasting.
EloraTZP Oral Presentations and Posters
EloraTZP Phase 1 Results: Adding eloralintide 3 mg to tirzepatide 5 mg led to 17% weight loss over 16 weeks versus 10% with tirzepatide 5 mg alone in adults with obesity or overweight.1
About
Zepbound
(tirzepatide) injection
Zepbound (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist obesity medication. Zepbound tackles an underlying cause of excess weight. It reduces appetite and how much you eat. Zepbound is indicated for adults with obesity, or some adults who are overweight and also have at least one weight-related medical problem, to lose weight and keep it off. Additionally, Zepbound is FDA-approved to treat adults with moderate-to-severe obstructive sleep apnea and obesity. Zepbound should be used with a reduced-calorie diet and increased physical activity.
About
Mounjaro
(tirzepatide) injection
Mounjaro (tirzepatide), the #1 prescribed branded type 2 diabetes medicine for adults in the U.S., is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). In adults with type 2 diabetes who are at high risk for cardiovascular events, Mounjaro is also indicated to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke. As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1).
About
Foundayo
(orforglipron)
Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.2 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.
About retatrutide
Retatrutide is an investigational once-weekly triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that is legally available only to participants in Lilly's clinical trials.
About
eloralintide
Eloralintide is an investigational once-weekly, selective amylin receptor agonist previously known as LY3841136. Eloralintide has the potential to decrease calorie intake, and the effects are likely mediated by affecting satiety, or the feeling of fullness. Phase 3 trials of eloralintide for the treatment of obesity and in adults with obesity or overweight with or without type 2 diabetes are currently ongoing. Lilly also conducted a Phase 2 study (NCT06603571) evaluating eloralintide, alone or in combination, with tirzepatide for weight management in adults with obesity or overweight and type 2 diabetes.
Endnotes
Data calculated using the efficacy estimand. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) without initiating prohibited weight management treatments (and glycemic rescue therapy for glycemic endpoints only).
Time to first event analysis using a Cox proportional hazard model. All data from randomization to the end of the study were included in the analysis.
All measures were multiplicity-controlled for type 1 error except weight and A1C reduction.
Results are based on median time.
U.S. ZEPBOUND INDICATIONS
AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:
obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.
Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.
Warnings
- Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.
KwikPen®: Do not share your
KwikPen
with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.
Zepbound may cause serious side effects, including:
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
Dehydration
leading
to
kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
Inflammation of
the pancreas
(pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.
Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin.
Signs and symptoms of low
blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.
Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.
Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep
sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.
Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
Tell your doctor if you have any side effects.
You can report side effects at 1-800-FDA-1088 or
.
Before using Zepbound
Your healthcare provider should show you how to use Zepbound before you use it for the first time.
Talk to your healthcare provider about low blood sugar and how to manage
it.
Tell
your
healthcare provider if you are taking medicines to treat diabetes including
an insulin or
sulfonylurea.
If you take birth control pills by mouth, talk to your healthcare provider before you use
Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.
Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).
How to take
Read the Instructions for Use that come with Zepbound.
Use Zepbound exactly as your healthcare provider says.
Use Zepbound with a reduced-calorie diet and increased physical activity.
Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen)thigh, or have another person inject in the back of the upper arm.
Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
Use Zepbound 1 time each week, at any time of the day.
Change (rotate) your injection site with each weekly injection.
Do not use the same site for each injection.
If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.
Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to
.
This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.
ZP CON
BS
25FEB2026
Zepbound®, its delivery device base and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
U.S. MOUNJARO INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Mounjaro® (mown-JAHR-OH) is an injectable prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults and children 10 years of age and older with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who are at high risk for these events.
It is not known if Mounjaro is safe and effective for use in children under 10 years of age.
Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.
Mounjaro may cause serious side effects, including:
Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.
Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.
Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.
Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures.
Common side effects
The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
Tell your healthcare provider if you have any side effects.
You can report side effects at 1-800-FDA-1088 or .
Before using Mounjaro
Your healthcare provider should show you how to use Mounjaro before you use it for the first time.
Talk to your healthcare provider about low blood sugar and how to manage it.
If you take birth control pills by mouth, talk to your healthcare provider before you use
Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take other diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby. Mounjaro may pass into your breast milk.
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
How to take
Read the
Instructions for Use that come with Mounjaro.
Use Mounjaro exactly as your healthcare provider says.
A caregiver may give you Mounjaro injections, or you may self-inject if a healthcare provider determines that it is appropriate.
Inject Mounjaro under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm.
Do not inject Mounjaro into a muscle (intramuscularly) or vein (intravenously).
Use
Mounjaro 1 time each week, at any time of the day.
Do not mix insulin and Mounjaro together in the same injection.
You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
Change (rotate) your injection site with each weekly injection.
Do not use the same site for each injection.
If you take too much Mounjaro, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Learn more
Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-800-LillyRX (800-545-5979) or go to
.
This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.
TR CON BS AUG2026
Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
U.S. FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS
Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
Foundayo should not be used with other GLP-1 receptor agonist medicines.
It is not known if Foundayo is safe and effective for use in children.
Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.
Foundayo
may cause serious side effects, including:
Inflammation of
the pancreas
(pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
Dehydration
leading
to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea.
Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.
Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.
Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.
Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.
Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.
Common side effects
The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.
Tell your doctor if you have any side effects.
You can report side effects at 1-800-FDA-1088 or
.
Before taking
Foundayo
Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.
Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
If you take birth control pills by mouth, talk to your healthcare provider before you take
Foundayo. Birth control pills may not work as well while taking
Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.
Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?
How to take
Take Foundayo exactly as your healthcare provider tells you to.
Use Foundayo with a reduced-calorie diet and increased physical activity.
Take Foundayo by mouth 1 time each day, with or without food.
Swallow tablets whole. Do not break, crush, or chew the tablet.
If you miss a dose, take it as soon as possible.
Do not take
2 doses of Foundayo in the same day.
Do not take more than 1 tablet per day.
If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Learn more
Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.
This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.
OG CON BS APR2026
U.S. Trulicity INDICATION[S]
AND
SAFETY
SUMMARY
WITH
WARNINGS
Trulicity® (Trū-li-si-tee) is for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.
It is not known if Trulicity is safe and effective to lower blood sugar (glucose) in children under 10 years of age.
Trulicity is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm.
Warnings: Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.
Ask your healthcare provider how to recognize the serious side effects below and what to do if you think you have one:
Inflammation of the pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes, you may feel the pain from your abdomen to your back.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes.
Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat.
Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Trulicity. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
Changes in vision. Tell your healthcare provider if you have changes in your eyesight (vision) during treatment with Trulicity.
Gallbladder problems. Gallbladder problems have happened in some people who take Trulicity. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), clay-colored stools.
Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Trulicity may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Trulicity before you are scheduled to have surgery or other procedures.
Common side effects
The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue.
These are not all the possible side effects of Trulicity.
Tell your healthcare provider if you have any side effects.
You can report side effects at 1-800-FDA-1088 or
.
Before using
Your healthcare provider should show you how to use Trulicity before you use it for the first time.
Before you use Trulicity, talk to your healthcare provider about low blood sugar and how to manage it.
Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?
❑ Do you take other diabetes medicines, such as insulin or sulfonylureas?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
How to take
Read the Instructions for Use that come with Trulicity.
Use Trulicity exactly as your healthcare provider says.
Inject Trulicity under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Trulicity into a muscle (intramuscularly) or vein (intravenously).
Do not share your Trulicity pen, syringe, or needles with another person.
Do not give Trulicity to other people.
If you take too much Trulicity, call your healthcare provider or Poison Helpline at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Learn more
Trulicity is a prescription medicine available as a pre-filled single-dose pen in 0.75 mg,1.5 mg, 3 mg, or 4.5 mg per 0.5 mL injection. For more information, call 1-800-LillyRx (1-800-545-5979) or go to .
This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Trulicity and how to take it. Your healthcare provider is the best person to help you decide if Trulicity is right for you.
DG CON HL BS 25MAR2026
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
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Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including about Foundayo (orforglipron), retatrutide, eloralintide, and eloraTZP as potential treatments for adults with obesity and/or type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to Foundayo, retatrutide, eloralintide and eloraTZP and its clinical trials, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that product candidates will prove to be safe and effective treatments for relevant indications or receive regulatory approval or additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
SOURCE Eli Lilly and Company
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