A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 Injection With Insulin Glargine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin, Metformin in Combination With or Without One Other Oral Antidiabetic Drug (OAD)

To compare the efficacy and safety of HR17031 injection and insulin glargine, including the changes of efficacy indicators such as HbA1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.

Start Date08 May 2024

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT06881264

/ CompletedPhase 3

A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)

The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents

Start Date30 Apr 2024

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT06086912

/ CompletedPhase 1

A Single-center, Randomized, Open, Three-period, Three-sequence Crossover Clinical Study to Compare the Bioavailability and Safety of a Single Subcutaneous Injection of HR17031 in Healthy Subjects at Different Sites

The purpose of this study is to evaluate the bioavailability and safety of HR17031 injection in healthy subjects at different sites.

Start Date07 Nov 2023

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with HR-17031

100 Translational Medicine associated with HR-17031

100 Patents (Medical) associated with HR-17031

Literatures (Medical) associated with HR-17031

01 Apr 2026·DIABETES OBESITY & METABOLISM

Pharmacokinetics and safety of HR17031 , a fixed‐ratio of INS068 /Noiiglutide combination, in Chinese patients with hepatic impairment

Article

Author: Ding, Yanhua ; Gao, Xuehu ; Lin, Hongda ; Wang, Di ; Diao, Lei ; Mai, Jiajia ; Zhang, Hong

Abstract:

Aims:

To evaluate the pharmacokinetics (PK) and safety of HR17031 (a fixed‐ratio combination of INS068 and Noiiglutide) in subjects with hepatic impairment.

Materials and Methods:

This open‐label, single‐dose, nonrandomised, parallel‐design trial enrolled 24 subjects with mild (Child–Pugh A), moderate (Child–Pugh B) and normal hepatic function ( n = 8 each). Participants received a single subcutaneous injection of HR17031 (10 U/0.024 mg). PK parameters of INS068 and Noiiglutide were determined by liquid chromatography–tandem mass spectrometry, free drug fractions were assessed by ultracentrifugation, and serum C‐peptide concentrations were measured. Safety was monitored throughout.

Results:

PK profiles of INS068 and Noiiglutide in subjects with mild hepatic impairment were comparable to those with normal function, while modest reductions were observed in moderate impairment (INS068 AUC 0–∞ geometric mean ratio [GMR]: 0.814 [0.703–0.944]; Noiiglutide AUC 0–∞ GMR: 0.713 [0.574–0.886]). Unbound fractions of both components and C‐peptide concentrations showed no significant differences across groups. HR17031 was well tolerated, and there were no serious adverse events.

Conclusions:

HR17031 demonstrated PK profiles of INS068 and Noiiglutide comparable between subjects with mild or moderate hepatic impairment and those with normal hepatic function, with modest reductions in moderate impairment. The treatment was well tolerated with a favourable safety profile, and no significant differences in C‐peptide concentrations were observed across groups.

01 Nov 2025·DIABETES OBESITY & METABOLISM

Efficacy and safety benefits of HR17031 , a fixed‐ratio combination of INS068 and noiiglutide, versus its components alone in Chinese patients with type 2 diabetes uncontrolled on oral antidiabetic drug(s): A phase 2, multicentre, open‐label, randomised, parallel three‐arm, treat‐to‐target trial

Article

Author: Mao, Li ; Zhao, Shi ; Sun, Qingyuan ; Huang, Debing ; Dong, Xue ; Wang, Quanren ; Lin, Xiang ; Li, Lu ; Ji, Linong ; Sun, Xiaodong ; Ye, Zi

Abstract:

Aims:

To assess the efficacy and safety of HR17031, a fixed‐ratio combination of basal insulin analogue (INS068) and GLP‐1 receptor agonist (noiiglutide), versus its components alone in patients with type 2 diabetes uncontrolled on metformin with or without a second oral antidiabetic drug.

Materials and Methods:

This phase 2 multicentre trial randomised 455 patients with type 2 diabetes (HbA1c 7.5%–11.0% [58.0–97.0 mmol/mol]; previous metformin ± another oral antidiabetic drug) 2:2:1 to HR17031 ( n = 183), INS068 ( n = 182) or noiiglutide ( n = 90). The primary endpoint was HbA1c change from baseline to week 26.

Results:

HR17031 achieved a greater reduction in HbA1c than INS068 and noiiglutide (−2.4% [−26 mmol/mol] vs. −1.5% [−16 mmol/mol] and −1.7% [−19 mmol/mol]), indicating superiority for HR17031 over both INS068 and noiiglutide (least‐squares mean difference = −0.9% [−10 mmol/mol] and −0.7% [−7 mmol/mol], respectively; both p < 0.0001). More patients reached HbA1c target <7.0% (53 mmol/mol) and ≤6.5% (48 mmol/mol) with HR17031 (<7.0%, 81.4%; ≤6.5%, 74.3%) than INS068 (47.8%; 26.4%) and noiiglutide (55.6%; 41.1%). HR17031 resulted in no weight gain in contrast to INS068 (−0.1 vs. 2.0 kg; p < 0.0001). Incidence of level 2/3 hypoglycaemia was similar with HR17031 (5.5%) and INS068 (4.4%), and lower with noiiglutide (1.1%). HR17031 demonstrated fewer instances of nausea (7.2%), diarrhoea (7.2%), and vomiting (2.8%) than noiiglutide (15.6%, 21.1%, and 20.0%).

Conclusions:

HR17031 is effective and well‐tolerated in patients with type 2 diabetes uncontrolled on metformin with or without a second oral antidiabetic drug.

News (Medical) associated with HR-17031

11 May 2024

·www.echemi.com

The Milestone in the Journey of Domestic Weight Loss Drugs: Hengrui's Breakthrough!

In recent news from Yaozh.com, Hengrui Pharmaceuticals, a leading player in the pharmaceutical industry, has taken a significant step forward in the development of domestic weight loss drugs. With the initiation of Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531, intended for obesity treatment, Hengrui aims to complete the study by July 2025. This move comes amidst the submission of a market application for a GLP-1R/GCGR dual agonist, Masidupeptide, by Xinda Biotechnology, positioning it as a potential pioneer in the field of domestically produced dual-target weight loss drugs. Hengrui Pharmaceuticals: Pioneering Innovations Hengrui Pharmaceuticals has established a strong presence in the field of metabolic disorders, including diabetes and obesity, in addition to their focus on oncology. With nine innovative drug pipelines dedicated to metabolic diseases, Hengrui has developed a range of drugs targeting various points such as DPP-IV, metformin, SGLT2, and insulin/GLP-1. Notably, three of their pipelines involve GLP-1 targeting, including HR17031, a drug for type 2 diabetes, and two promising GLP-1 weight loss drugs, HRS-7535 and HRS9531. The GLP-1 weight loss drug market is highly competitive, with newcomers needing to demonstrate distinctive advantages to gain market share from established giants like Lilly and Novo Nordisk. Hengrui's strategy involves developing an orally administered small molecule GLP-1 receptor agonist, HRS-7535. This formulation offers improved portability and ease of use compared to injectable forms, enhancing patient compliance. Furthermore, HRS-7535 holds the advantage of being the first oral small molecule GLP-1 drug without any existing global competitors. Currently, HRS-7535 is in Phase II clinical trials for both type 2 diabetes and weight loss indications. Initial results from Phase I studies indicate its favorable safety, tolerability, pharmacokinetic profile, and potential to reduce weight by 4.38 kg after four weeks of treatment, with notable hypoglycemic effects. Xinda Biotechnology: The Dual-Target Approach Xinda Biotechnology has taken a significant stride in the development of dual-target weight loss drugs with its GLP-1R/GCGR dual agonist, Masidupeptide. Having received acceptance for market application by the National Medical Products Administration (NMPA) in February of this year, Masidupeptide is poised to become the first domestically produced dual-target weight loss drug. The results from Phase II clinical studies demonstrate an average percentage change in weight reduction of -15.4% compared to the placebo group, with a weight loss of 14.7 kg after 24 weeks of treatment. In clinical studies primarily conducted on the Chinese population, Masidupeptide has shown superior weight reduction efficacy (18.6%) compared to Lilly's dulaglutide and Novo Nordisk's semaglutide. Hengrui's HRS9531: A Promising Contender Following closely behind Xinda Biotechnology, Hengrui Pharmaceuticals has initiated Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531, designed for obesity treatment. The study is expected to be completed by July 2025. Initial results from Phase I studies indicate weight reductions ranging from 4.3-7.7 kg (6.7%-9.3%) after four weeks of treatment with HRS9531 at doses ranging from 0.9-5.4 mg. The greatest weight reduction (8.0 kg, 10.0%) was observed on the 36th day in the 5.4 mg dose group. Although Hengrui's research and development progress slightly lags behind Xinda Biotechnology, their strong sales and marketing capabilities make the ultimate sales performance of these two contenders difficult to predict. The Competitive Landscape for Domestic Players Time is of the essence for domestic pharmaceutical companies in the Chinese market. Both Novo Nordisk's semaglutide and Lilly's dulaglutide, with weight loss indications, have already submitted market applications and are expected to be approved for sale in the near future, setting the stage for intense competition in the GLP-1 weight loss drug market. Moreover, there is a significant level of competition among domestic players in this field. Dozens of GLP-1 pipelines are currently in various stages of clinical development. Apart from Xinda Biotechnology and Hengrui Pharmaceuticals, other listed pharmaceutical companies, such as Huadong Medicine, Hanson Pharmaceutical, and Borui Medicine, are alsoactively pursuing the development of GLP-1 weight loss drugs. The race to develop domestically produced weight loss drugs in China has reached a critical milestone with Hengrui Pharmaceuticals' initiation of Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531. Alongside Xinda Biotechnology's market application for their GLP-1R/GCGR dual agonist, Masidupeptide, the domestic weight loss drug market is poised for intense competition. Hengrui's innovative pipeline, including the orally administered GLP-1 receptor agonist, HRS-7535, showcases their commitment to providing patients with effective and convenient treatment options. However, success in this market will depend on factors such as production capacity, marketing strategies, and ongoing research and development efforts. As the journey progresses, various domestic pharmaceutical companies, including Hengrui and Xinda, are taking significant steps forward, aiming to claim their share of the weight loss drug market and improve the health and well-being of individuals struggling with obesity.

Phase 2Phase 1Phase 3Clinical Result

100 Deals associated with HR-17031

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	14 Mar 2026
liver function failure	Phase 1	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	11 Jan 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2026	Phase 3	Diabetes Mellitus, Type 2	393	HR17031	vuugjwjtcz(btntbwmwgl) = zjgpipriuk rmdxxtalau (uxuvkjxvbk ) View more	Positive	20 Jun 2026
				Insulin Glargine (iGlar)	vuugjwjtcz(btntbwmwgl) = izijgpooom rmdxxtalau (uxuvkjxvbk ) View more
NCT05333835 (ADA2024) Manual	Phase 2	Diabetes Mellitus, Type 2	455	HR17031	nxlrwjdzdx(fyxcbqarxg) = csmxedslfl mntilxtgax (zxckjqcjzf ) View more	Positive	21 Jun 2024
				INS068	nxlrwjdzdx(fyxcbqarxg) = aoycyubgst mntilxtgax (zxckjqcjzf ) View more

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