A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

Start Date01 Dec 2025

Sponsor / Collaborator

Eli Lilly & Co.

CTR20254566

/ RecruitingPhase 3

一项在合并肥胖或超重的压力性尿失禁女性参与者中评价orforglipron 片剂每日一次给药与安慰剂相比的有效性和安全性的研究（RESTRAIN-SUI）

[Translation] A study evaluating the efficacy and safety of once-daily orforglipron tablets compared to placebo in female participants with stress urinary incontinence who were obese or overweight (RESTRAIN-SUI).

压力性尿失禁（SUI）是一个重大的女性健康问题，对生活质量有显著影响。Orforglipron 是一种可能通过减轻体重继而改善肥胖或超重参与者的SUI症状的药物治疗选择。本研究旨在肥胖或超重女性参与者中评价orforglipron在减轻SUI症状方面的有效性和安全性。

[Translation]

Stress urinary incontinence (SUI) is a significant health problem for women, with a substantial impact on their quality of life. Orforglipron is a potential treatment option that may improve SUI symptoms in obese or overweight participants by reducing weight. This study aimed to evaluate the efficacy and safety of orforglipron in reducing SUI symptoms in obese or overweight female participants.

Start Date28 Nov 2025

Sponsor / Collaborator

Eli Lilly Suzhou Pharmaceutical Co. Ltd.

[+2]

NCT07223593

/ RecruitingPhase 3

A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial

The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.

Start Date31 Oct 2025

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Orforglipron

100 Translational Medicine associated with Orforglipron

100 Patents (Medical) associated with Orforglipron

Literatures (Medical) associated with Orforglipron

01 Feb 2026·EBioMedicine

Generation and characterisation of a humanised GLP-1 receptor mouse model for translational drug development

Article

Author: Gaidarov, Ibragim ; Cavalera, Michele ; Riis, Malene Lundgaard ; Porsgaard, Trine ; Feigh, Michael ; Jones, Christopher ; Pors, Susanne E ; Quinn, Kevin ; Zachariassen, Line Fisker ; Thorbek, Ditte Dencker ; Anthony, Todd ; Tozzi, Marco ; Hansen, Henrik H ; Roque, Micaela ; Osborn, Olivia ; Sonne, Nina

BACKGROUND:

Injectable peptide-based glucagon-like peptide-1 receptor (GLP1R) agonists (GLP1RAs) are effective treatments for obesity and diabetes but are limited by patient compliance and scalability challenges. In contrast, non-peptide small-molecule GLP1RAs offer the advantage of oral delivery but are relatively inactive at the rodent GLP1R, limiting their utility in preclinical pharmacodynamic studies. This study aimed to bridge the translational gap by engineering and thoroughly validating a humanised GLP-1 receptor (hGLP1R) mouse model that more accurately recapitulates human receptor pharmacology, thereby enhancing its utility for preclinical drug development.

METHODS:

The hGLP1R mouse was generated via CRISPR-Cas9-mediated replacement of the endogenous murine Glp1r gene with the human orthologue. The hGLP1R mouse model was pharmacologically characterised using peptide (semaglutide) and small-molecule (orforglipron) GLP1RAs in lean and diet-induced obese (DIO) hGLP1R and wild-type (WT) mice.

FINDINGS:

Immunohistochemistry confirmed expression of the human GLP1R and complete absence of the endogenous murine GLP1R in pancreatic β-cells and key appetite-regulatory brain regions of hGLP1R mice. In lean hGLP1R mice, both semaglutide and orforglipron significantly reduced body weight and food intake, improved glucose tolerance, and induced taste aversion. CNS response profiles were evaluated using high-resolution 3D whole-brain imaging, revealing overlapping c-Fos activation patterns for both agonists. In DIO hGLP1R mice, chronic administration of either compound produced robust reductions in body weight, food intake and plasma lipids. Notably, orforglipron was inactive in WT mice, which responded only to semaglutide.

INTERPRETATION:

These findings establish the hGLP1R mouse as a robust and translational platform for advancing the discovery and evaluation of novel small-molecule GLP1RAs targeting obesity and related metabolic diseases.

FUNDING:

This research was funded by Gubra A/S and Terns Pharmaceuticals, Inc.; there was no external funding.

01 Feb 2026·Journal of Diabetes Investigation

A phase 1 single and multiple ascending dose study of orforglipron in Japanese participants with type 2 diabetes

Article

Author: Nakamura, Chino ; Hirase, Tetsuaki ; Takenouchi, Kazumasa ; Ohwaki, Kenji ; Nasu, Risa

ABSTRACT:

Introduction:

We aimed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of orforglipron in Japanese participants with type 2 diabetes.

Materials and Methods:

This was a double‐blind, placebo‐controlled, randomized, phase 1 study. In Part A, participants received single doses of orforglipron (2 or 3 mg) or placebo. In Part B, participants received multiple ascending doses of daily oral orforglipron (final target doses: 12, 24, and 45 mg) or placebo for 12 weeks.

Results:

Parts A and B enrolled 23 and 60 participants, respectively. The most common treatment‐emergent adverse events were gastrointestinal events of mild severity. No severe or serious adverse events were reported. At week 12, median tmax was 5.92–8.00 h, and mean terminal half‐life was 51.8–76.1 h. Following multiple ascending doses, orforglipron groups had greater mean reductions from baseline to week 12 in glycemic parameters (fasting glucose: orforglipron 12 mg −64.8 mg/dL, 24 mg −61.1 mg/dL, 45 mg −65.6 mg/dL, placebo 7.4 mg/dL; glycated hemoglobin: orforglipron 12 mg −2.16%, 24 mg −2.17%, 45 mg −2.28%, placebo 0.67%) and body weight (orforglipron 12 mg −2.9 kg, 24 mg −6.3 kg, 45 mg −4.8 kg, placebo 0.3 kg) compared with placebo.

Discussion:

In Japanese participants, safety, pharmacokinetic, and pharmacodynamic results were similar to those of previous orforglipron studies. The safety and tolerability of orforglipron were also consistent with those of other glucagon‐like peptide‐1 receptor agonists. Orforglipron is a potential new treatment option for Japanese patients with type 2 diabetes.

01 Jan 2026·Clinical Pharmacology in Drug Development

Disposition and Absolute Bioavailability of Orally Administered Orforglipron in Healthy Participants

Article

Author: Nicoll, Clare ; Morse, Bridget L. ; Czeskis, Boris ; Coutant, David E. ; Ma, Xiaosu ; Cassidy, Kenneth C. ; Bhattachar, Shobha

Abstract:

Orforglipron is a non‐peptide, oral glucagon‐like peptide 1 receptor agonist under development for glycemic control in adults with type 2 diabetes and weight management in people with obesity. Two phase 1, open‐label studies evaluated the disposition and absolute bioavailability of orforglipron in healthy adults. Study A participants (N = 10) received a 1‐mg orforglipron oral capsule while fasting and an intravenous dose of ∼21 µg of [14C]‐orforglipron. Study B participants (N = 6) received an oral solution of 3 mg of orforglipron with ∼200 µCi of [14C]‐orforglipron while fasting. In study A, total plasma radioactivity and [14C]‐orforglipron were measured by accelerator mass spectrometry (AMS) and high‐performance liquid chromatography (HPLC)/AMS, while orforglipron was measured by HPLC/MS. The mean absolute oral bioavailability of orforglipron was 79.1% ± 16.8%. In study B, urine and feces were analyzed for total radioactivity. Metabolic radioprofiling was performed on selected plasma and fecal samples by HPLC/high‐resolution MS. The primary route of elimination for [14C]‐orforglipron‐related radioactivity was via the feces (87% ± 2.8%) with minimal urinary excretion (0.2% ± 0.02%). Total recovery of administered radioactivity was 88% over 384 hours after the dose. Metabolite profiling from study B showed that orforglipron underwent extensive oxidative metabolism, followed by microbial metabolism of the oxadiazolone ring. Orforglipron was the most abundant plasma component (93.3%) with minor oxidative metabolites M7 (3.3%) and M23 (1.6%).

243

News (Medical) associated with Orforglipron

04 Feb 2026

·www.fiercepharma.com

Even with pricing headwinds, Eli Lilly expects sales surge to continue in 2026

Eli Lilly acknowledged that it will be impacted significantly by pricing pressures in 2026 for its juggernaut tirzepatide products Mounjaro and Zepbound. But the company's momentum is such that it still expects revenues to reach between $80 billion and $83 billion, which would be a 25% increase at the midpoint on 2025 sales. After Novo Nordisk projected yesterday that its revenue could decline by as much as 13% in 2026, its share price has plummeted by 20%.Because the Danish company attributed much of the shortfall to pricing pressures, its rival in the diabetes and obesity market, Eli Lilly, also sustained a slide in its share price of 5% on Tuesday, as investors assumed the pricing effects would also apply to the Indianapolis company.Today, when Lilly presented its quarterly earnings, it acknowledged the negative pricing factors but also projected a significant increase in sales this year. The guidance, combined with its report of booming sales in the fourth quarter, prompted a 10% surge in Lilly’s shares, more than compensating for their decline the previous day.Such is the momentum of the world’s most valuable drugmaker, which three months ago became the first in industry history to achieve a market cap of $1 trillion.Lilly is projecting 2026 sales to come in at between $80 billion and $83 billion. The midpoint of the window represents a 25% increase on Lilly's 2025 sales of $65.2 billion. The 2026 projection sounds conservative, given that the company increased its sales by 45% last year.“We expect to deliver industry-leading volume growth, driven by our key products, partially offset by our lower realized prices,” Lucas Montarce, Lilly’s chief financial officer, explained on a conference call. “Price is expected to be a drag on growth in the low- to mid-teens.”Montarce specified three factors playing into Lilly’s price projections for its juggernaut metabolic products—diabetes treatment Mounjaro, obesity drug Zepbound and investigational weight-loss pill orforglipron, which is expected to reach the market in the first half of this year.One of the factors is Lilly’s agreement with the White House to sell Zepbound and orforglipron at cut-rate prices to U.S. patients. Another is the company’s direct-to-patient pricing plan for multi-dose pens of Zepbound. Additionally, Mounjaro’s inclusion on China’s national reimbursement drug list for type 2 diabetes will bring down prices, as well.One more factor Lilly cited is lower Medicaid pricing for later-lifecycle products, such as the psoriasis drug Taltz, the diabetes medicine Trulicity and the breast cancer treatment Verzenio.“We believe these price concessions will be more than offset by increased volume over time as we expand the number of people who can benefit from Lilly medicines,” Montarce said.In a note to investors, Cantor Fitzgerald analyst Carter Gould said Lilly "delivered the standout print" of the fourth quarter, "easily bettering Street estimates with broad geographic strength across the tirzepatide franchise, and an assertive ’26 guide that should counter critics."Gould added that Lilly's report "stands in stark contrast" to the market "optics" presented by Novo."The high-end, the low-end, the narrower guide—all of it—express a far more confident view of the market than most of the Street were anticipating," Gould added. Sales of Lilly’s tirzepatide products continued to scale up remarkably in the fourth quarter of 2025, smashing analyst expectations. Mounjaro generated $7.4 billion in the period, which was up 110% year over year and an increase sequentially from $6.5 billion. Analyst consensus had pegged Q4 sales of Mounjaro at $6.7 billion. Additionally, Mounjaro chalked up sales outside of the U.S. of $3.3 billion.Meanwhile, Zepbound raked in $4.3 billion in the quarter, which was up 123% year over year and an increase from $3.6 billion in the third quarter. The Q4 figure exceeded the analyst estimate of $3.8 billion.For 2025 overall, combined sales of Mounjaro and Zepbound reached $36.5 billion, which accounted for 56% of Lilly’s revenue and made tirzepatide the world’s best-selling drug. The tirzepatide duo outpaced Novo’s semaglutide treatments Ozempic and Wegovy, which generated combined sales of $33 billion, and Merck’s cancer therapy Keytruda, which pulled in sales of $31.7 billion. As for how the potential approval of orforglipron will affect the overall sales of Lilly's cardiometabolic treatments, CEO David Ricks called it a “bit of a wild card in our short- and mid-term outlook.”“I am hard pressed to think of an analog where you have this many people paying out of pocket for a prescription medication,” Ricks added.

Biosimilar

04 Feb 2026

·www.fiercebiotech.com

Lilly drops 3 pipeline drugs, including gene therapy from $1B Prevail buyout

Over the last few years, Lilly has zeroed in on its next-gen obesity candidates, including small molecule orforglipron. \n As Eli Lilly awaits an FDA approval decision for its oral GLP-1 orforglipron, the pharma has discarded three clinical-stage drugs, including a gene therapy from its $1 billion acquisition of Prevail Therapeutics.The therapy was being studied as a treatment for a specific type of frontotemporal dementia (FTD) that relates to changes in the progranulin (GRN) gene. Aptly named FTD-GRN, the neurodegenerative disease is primarily inherited and can lead to changes in behavior and executive functioning.Lilly’s gene therapy for the condition stems from its $1 billion-plus buyout of Prevail Therapeutics back in 2020. Dubbed LY3884963—and formerly known as PR006—the therapy entered a phase 1/2 trial in 2020 and was in the later stage of the study. The trial included five different treatment cohorts across various doses, dosing manners and phases of disease.“Lilly discontinued GRN gene therapy in frontotemporal dementia due to a lack of compelling efficacy in the studied patient population. The decision was not due to any safety concern,” a spokesperson told Fierce.The study was slated for a primary readout in 2031, according to ClinicalTrials.gov. The trial’s main goal was to assess the safety and effect of the therapy on GRN levels. Patients already enrolled in the study will be included in a safety follow-up period, according to the Lilly spokesperson.“We aim to leverage insights gained from this program in upcoming interventions and are planning to share the data at a forthcoming scientific meeting,” the spokesperson added. The big pharma is still continuing development for several other gene therapies, including a mid-stage GBA1 gene therapy that Prevail had touted as its lead asset. The candidate is being studied in trials for both Parkinson’s disease and Gaucher disease type 1.And just last week, Lilly inked a deal potentially worth more than $1 billion to get in on the development of a genetic medicine for hearing loss from Seamless Therapeutics. Next on the chopping block is LY3541860, an anti-CD19 antibody tested out in mid-stage studies for both multiple sclerosis (MS) and rheumatoid arthritis (RA).In the RA trial, the autoimmune asset was being evaluated for its ability to impact disease activity compared to baseline among 35 patients, according to ClinicalTrials.gov. The phase 2a study’s primary readout was scheduled for November of last year. “The termination was not safety-driven,” Lilly’s spokesperson said. “The asset did not meet Lilly’s high bar for continued development.” Meanwhile, the MS phase 2a/2b trial for LY3541860 is slated to readout in August of 2027, according to the federal database. The expected four-year study aimed to enroll 200 patients and was most recently listed as \"recruiting.\" Previously, preclinical models demonstrated that the anti-CD19 antibody was a “highly potent B cell inhibitor that may have potential to demonstrate improved efficacy over currently available B cell-targeting therapies in treatment of autoimmune conditions without causing B cell depletion.”Lastly, Lilly is ditching AC-225-PSMA-62, an investigational radioligand therapy that was being studied in a phase 1/2 trial for prostate cancer. More specifically, the trial enrolled patients with prostate-specific membrane antigen (PSMA)-positive cancer with limited spread. The study’s primary readout was scheduled for September 2027.AC-225-PSMA-62 didn’t meet Lilly’s “bar for differentiated efficacy to advance to phase 2,” according to the spokesperson. The termination wasn’t related to “any new or unexpected safety findings,” they added. When asked if any layoffs were associated with the pipeline cuts, the spokesperson said, “There are no large-scale workforce reductions underway at Lilly. We continuously evaluate our business model and routinely make workforce adjustments to enhance our speed, agility and ability to deliver the best medicines to patients.”In the most recent quarter, Lilly’s R&D spend rose 26% to $3.8 billion, or 20% of revenue, according to the company’s earnings report. Over the last few years, the tirzepatide developer has zeroed in on its next-gen obesity candidates, including small molecule orforglipron. Lilly has snared a Commissioner’s National Priority Voucher that could accelerate an approval decision for orforglipron.

Phase 2Gene TherapyAcquisition

04 Feb 2026

·www.prnewswire.com

Lilly reports fourth-quarter 2025 financial results and provides 2026 guidance

Revenue in Q4 2025 increased 43% to $19.3 billion driven by volume growth from Mounjaro and Zepbound. Q4 2025 EPS increased by 51% to $7.39 on a reported basis and increased by 42% to $7.54 on a non-GAAP basis, both inclusive of $0.52 of acquired IPR&D charges. Regulatory progress included FDA approval of Kwikpen for tirzepatide and an expanded indication for Jaypirca, and submissions for orforglipron for obesity to regulatory authorities in the U.S. and Japan and for obesity and type 2 diabetes in the EU. Pipeline progress included positive Phase 3 results from Taltz and Zepbound used together for adults with active psoriatic arthritis and obesity, orforglipron for people who switched from injectable incretins to oral GLP-1 therapy, and retatrutide for people with obesity and knee osteoarthritis. Announced an agreement with the U.S. government to expand access to obesity medicines for millions of Americans. 2026 guidance issued with revenue in the range of $80 billion to $83 billion and non-GAAP EPS in the range of $33.50 to $35.00. INDIANAPOLIS, Feb. 4, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced its financial results for the fourth-quarter of 2025 and provided 2026 financial guidance. "2025 was an important year for Lilly," said David A. Ricks, Lilly's chair and CEO. "We reached millions more patients—launching Inluriyo, expanding Mounjaro and Kisunla globally, and submitting orforglipron for approval. We expanded our manufacturing capacity, and through our U.S. government agreement, opened new access to obesity medicines. Entering our 150th year with a deep pipeline and platforms like LillyDirect, we're positioned to reach more patients than ever and expand our global health impact." Financial Results A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)." Fourth-Quarter Reported Results In Q4 2025, worldwide revenue was $19.3 billion, an increase of 43% compared with Q4 2024, driven by a 46% increase in volume, partially offset by a 5% decrease due to lower realized prices. Key Products[1] revenue grew to $13.8 billion in Q4 2025, led by Mounjaro and Zepbound. Revenue in the U.S. increased 43% to $12.9 billion, driven by a 50% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices were driven by Zepbound and Mounjaro. Revenue outside the U.S. increased 43% to $6.4 billion, driven by a 38% increase in volume and to a lesser extent a 4% favorable impact on foreign exchange rates. The volume increase outside the U.S. was driven primarily by Mounjaro, partially offset by Jardiance. Volume growth was negatively impacted by a one-time benefit of $300 million related to Jardiance, associated with an amendment to the company's collaboration with Boehringer Ingelheim, in Q4 2024. Gross margin increased 43% to $15.9 billion in Q4 2025. Gross margin as a percent of revenue was 82.5%, an increase of 0.3 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and improved cost of production, partially offset by lower realized prices. In Q4 2025, research and development expenses increased 26% to $3.8 billion, or 20% of revenue, driven by continued investments in the company's early and late-stage portfolio. Marketing, selling and administrative expenses increased 29% to $3.1 billion in Q4 2025, primarily driven by promotional efforts supporting ongoing and planned launches. The effective tax rate was 19.7% in Q4 2025 compared with 12.5% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025. In Q4 2025, net income and earnings per share (EPS) were $6.6 billion and $7.39, respectively, compared with net income of $4.4 billion and EPS of $4.88 in Q4 2024. EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively. Fourth-Quarter Non-GAAP Measures On a non-GAAP basis, Q4 2025 gross margin increased 42% to $16.0 billion. Gross margin as a percent of revenue was 83.2%, consistent with Q4 2024. Favorable product mix and improved cost of production were offset by lower realized prices. The non-GAAP effective tax rate was 19.7% in Q4 2025 compared with 13.2% in Q4 2024 primarily driven by a less favorable jurisdictional mix of earnings in Q4 2025 relative to Q4 2024. Additionally, the effective tax rate for Q4 2025 was unfavorably impacted by U.S. tax law changes enacted earlier in 2025. On a non-GAAP basis, Q4 2025 net income and EPS were $6.8 billion and $7.54, respectively, compared with net income of $4.8 billion and EPS of $5.32 in Q4 2024. Non-GAAP EPS in Q4 2025 and Q4 2024 included acquired IPR&D charges of $0.52 and $0.19, respectively. For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release. Selected Revenue Highlights Mounjaro For Q4 2025, worldwide Mounjaro revenue increased 110% to $7.4 billion. U.S. revenue was $4.1 billion, an increase of 57%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $3.3 billion compared with $899 million in Q4 2024, primarily driven by volume growth. Zepbound For Q4 2025, U.S. Zepbound revenue increased 122% to $4.2 billion, compared with $1.9 billion in Q4 2024, primarily driven by increased demand, partially offset by lower realized prices. Verzenio For Q4 2025, worldwide Verzenio revenue increased 3% to $1.6 billion. U.S. revenue was $997 million, a decrease of 4%. Revenue outside the U.S. was $608 million, an increase of 18%, primarily driven by volume growth. Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including: For information on important public announcements, visit the news section of Lilly's website. 2026 Financial Guidance In addition to providing guidance for GAAP revenue, Lilly provides guidance for certain non-GAAP measures. Lilly does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because comparable GAAP measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for a reconciliation. In particular, Lilly cannot reasonably predict certain items including net gains and losses on equity securities, asset impairment, acquisition or divestiture-related items, restructuring and other adjustments, without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on Lilly's reported results in accordance with GAAP. The following table summarizes the company's full-year 2026 financial guidance: Webcast of Conference Call As previously announced, investors and the general public can access a live webcast of the Q4 2025 financial results conference call through a link on Lilly's website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website. Non-GAAP Financial Measures Certain financial information is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Historical non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. Related materials provide certain GAAP and non-GAAP figures excluding the impact of foreign exchange rates. Lilly recalculates current period figures on a constant currency basis by keeping constant the exchange rates from the base period. The company's 2026 financial guidance (other than revenue) is provided on a non-GAAP basis, as described in "2026 Financial Guidance" above. Non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business. 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 nearly 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. F-LLY Cautionary Statement Regarding Forward-Looking Statements This press release and the related attachments contain management's intentions and expectations for the future, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "project", "intend", "expect", "believe", "target", "plan", "anticipate", "may", "could", "aim", "seek", "will", "continue", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. The following include some but not all of the factors that could cause actual results or events to differ from those anticipated, including the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory approvals and the ability of the company's clinical trials to meet expectations; the impact and uncertain outcome of acquisitions and business development transactions and related costs; intense competition affecting the company's products, pipeline, or industry; market uptake of launched products and indications; continued pricing pressures and the impact of actions of governmental and private actors affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto; the negotiation and implementation of our voluntary agreement with the U.S. government related to drug pricing and access; Developments or uncertainties related to our or competitive products, including as may relate to safety or efficacy concerns; dependence on relatively few products or product classes for a significant percentage of the company's total revenue and a consolidated supply chain; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products; the company's ability to protect and enforce patents and other intellectual property and changes in patent law or regulations related to data package exclusivity; information technology system inadequacies, inadequate controls or procedures, security breaches, or operating failures; unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in the company's information technology systems, networks, and facilities, or those of third parties with whom the company shares its data and violations of data protection laws or regulations; issues with product supply, regulatory approvals, or other negative outcomes stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to the company's and third-party facilities; reliance on third-party relationships and outsourcing arrangements; the use of artificial intelligence or other emerging technologies in various facets of the company's operations, including partnerships related to the use of, or the sharing of such technologies with third parties, which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks; the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade and other global disputes and interruptions, including related to tariffs, trade protection measures, and similar restrictions, international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally; fluctuations in foreign currency exchange rates, changes in interest rates and inflation or deflation; significant and sudden declines or volatility in the trading price of the company's common stock and market capitalization; litigation, investigations, or other similar proceedings involving past, current, or future products, activities, or intellectual property; changes in tax law and regulations, tax rates, or events that differ from our assumptions related to tax positions; regulatory changes, developments, and uncertainty; regulatory oversight and actions regarding the company's operations and products; regulatory compliance problems or government investigations; risks from the proliferation of counterfeit, misbranded, adulterated, diverted or illegally compounded products; actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations; asset impairments and restructuring charges; and changes in accounting and reporting standards. For additional information about the factors that could cause actual results or events to differ materially from forward-looking statements, please see the company's latest Form 10-K and subsequent Forms 8-K and 10-Q filed with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements contained in this press release and the related attachments, which, except as otherwise noted, speak only as of the date of this release. Except as is required by law, the company expressly disclaims any obligation to publicly release any revisions to forward-looking statements contained in this press release and the related attachments to reflect events or circumstances after the date of this release. Website Information The information contained on, or that may be accessed through, our website or any third-party website is not incorporated by reference into, and is not a part of, this earnings release. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Financial StatementClinical ResultPhase 3Drug Approval

100 Deals associated with Orforglipron

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	NDA/BLA	United States	Eli Lilly & Co.	18 Dec 2025
Carotid Artery Diseases	Phase 3	China	Eli Lilly & Co.	04 Dec 2025
Carotid Artery Diseases	Phase 3	Argentina	Eli Lilly & Co.	04 Dec 2025
Carotid Artery Diseases	Phase 3	Australia	Eli Lilly & Co.	04 Dec 2025
Coronary Disease	Phase 3	China	Eli Lilly & Co.	04 Dec 2025
Coronary Disease	Phase 3	Argentina	Eli Lilly & Co.	04 Dec 2025
Coronary Disease	Phase 3	Australia	Eli Lilly & Co.	04 Dec 2025
Ischemic stroke	Phase 3	China	Eli Lilly & Co.	04 Dec 2025
Ischemic stroke	Phase 3	Argentina	Eli Lilly & Co.	04 Dec 2025
Ischemic stroke	Phase 3	Australia	Eli Lilly & Co.	04 Dec 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06192108 \| NCT06109311 (ACHIEVE-5, Company_Website) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Orforglipron 3 mg + metformin (ACHIEVE-2)	wgrzydrrwi(qyswgnmtrh) = sksxyjhgms kpvlrfginb (cplwivpyjb ) Met View more	Superior	15 Oct 2025
				Orforglipron 12 mg + metformin (ACHIEVE-2)	wgrzydrrwi(qyswgnmtrh) = indiiltdty kpvlrfginb (cplwivpyjb ) Met View more
NCT06045221 (ACHIEVE-3, PRNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	1,698	orforglipron 12 mg	fyubprdjpz(bbizaggwvl) = zzwcqwoled mchogllmkw (iozxlrgywk ) Met View more	Superior	17 Sep 2025
				orforglipron 36 mg	fyubprdjpz(bbizaggwvl) = anlsdclpfg mchogllmkw (iozxlrgywk ) Met View more
NCT05869903 (ATTAIN-1, Company_Website \| N Engl J Med) Manual	Phase 3	Obesity	-	Orforglipron 6 mg	sojgpaoqos(qrxzbglerj) = oawbzwyahx fnzyejtedj (ggcwhzvvkw ) Met View more	Positive	16 Sep 2025
				Orforglipron 12 mg	sojgpaoqos(qrxzbglerj) = rvtgywtoxf fnzyejtedj (ggcwhzvvkw ) Met View more
NCT05872620 (ATTAIN-2, Company_Website) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Overweight \| Obesity	-	Orforglipron 6 mg	bgwimosgoz(lsksutlrmx) = svfpwimqca skjvwlwmjj (hzsxyjelzb ) View more	Positive	26 Aug 2025
				Orforglipron 12 mg	bgwimosgoz(lsksutlrmx) = mgsqccqisc skjvwlwmjj (hzsxyjelzb ) View more
NCT05869903 (ATTAIN-1, NEWS) Manual	Phase 3	Overweight \| Obesity	-	orforglipron	ubcmpwrpjl(nilvlayolj) = orforglipron的三个剂量组与安慰剂组相比均达到了主要终点 vzmenutyjw (upedepgdhf ) Met View more	Positive	07 Aug 2025
				安慰剂
NCT05971940 (ACHIEVE-1, Pubmed \| N Engl J Med) Manual	Phase 3	Diabetes Mellitus, Type 2	559	Orforglipron 3 mg	caklvxpelg(tkjwbanuhs) = fvjmvdwdct cjxrrmgyyw (naylvnjvsj ) View more	Positive	21 Jun 2025
				Orforglipron 12 mg	caklvxpelg(tkjwbanuhs) = ucpsjlkotp cjxrrmgyyw (naylvnjvsj ) View more
NCT05971940 (ACHIEVE-1, Biospace \| NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	559	Orforglipron 3 mgOrforglipron 3 mg	zqsepzsdol(nvstiiepra) = zlbfzetodf nchhhpzuwb (jmmtanoemu ) Met View more	Positive	17 Apr 2025
				OrforglipronOrforglipron 12 mg	zqsepzsdol(nvstiiepra) = lrbjnnzmum nchhhpzuwb (jmmtanoemu ) Met View more
NCT05051579 (EASD2023)	Phase 2	Overweight \| Obesity	272	Orforglipron (OFG) 12 mg	tvmrpmueiq(nzlzzhfevq) = hgtsxicvzt wqgntpmaau (wnqcgidlpk ) View more	Positive	03 Oct 2023
				Orforglipron (OFG) 24 mg	tvmrpmueiq(nzlzzhfevq) = vpulgzyzfq wqgntpmaau (wnqcgidlpk ) View more
NCT05051579 (GZGI, CTgov)	Phase 2	Obesity	272	LY3502970 (24 mg LY3502970)	ivabkeowli(isnprjtyvv) = ghwvozysdj kdplelqeby (tehezvryot, 0.82) View more	-	13 Sep 2023
				Placebo (Placebo)	ivabkeowli(isnprjtyvv) = tpeegfdhot kdplelqeby (tehezvryot, 0.81) View more
NCT05048719 (ADA 12023 \| ADA 22023) Manual	Phase 2	Diabetes Mellitus, Type 2	383	Orforglipron 3 mg	pddpzvmpqo(zesamxesqf) = lgtstbipoj iyftgenubk (uvnwjbtadr ) View more	Positive	25 Jun 2023
				Orforglipron 12 mg	pddpzvmpqo(zesamxesqf) = zbfirkdghj iyftgenubk (uvnwjbtadr ) View more

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