ribupatide injection (HRS9531 injection) / Jiangsu Hengrui Pharma, Kailera Therapeutics - LARVOL DELTA

Preclinical and First-In-Human Evaluation of Ribupatide (HRS9531), a Dual GLP-1/GIP Receptor Agonist. (PubMed, Diabetes Obes Metab) - P1 | "Ribupatide exhibited a favourable safety and tolerability profile, along with PK properties consistent with once-weekly administration. Its glucose-lowering and weight-loss effects support further clinical development for the treatment of type 2 diabetes mellitus and obesity."

First-in-human • Journal • P1 data • Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-4729, a novel GLP-1/GIP/glucagon triple-receptor agonist: a randomised, double-blind, placebo-controlled Phase 1 study (EASD 2026) - P1 | "In the multiple ascending dose (MAD) part, adults living with obesity (BMI 28-40 kg/m 2 ) and without diabetes were randomized to receive weekly HRS-4729 (1mg fixed dose; 4, 8, or 12 mg with titration), placebo, or weekly ribupatide injection (4 mg titration) for 12 weeks. HRS-4729 showed an acceptable safety profile similar to other incretin-based medications, and the PK data supports once-weekly administration. These findings, together with the favorable weight loss effect, support further development of HRS-4729 in obesity."

Clinical • First-in-human • Late-breaking abstract • P1 data • PK/PD data • Diabetes • Metabolic Disorders • Obesity

Effect of injection site on the relative bioavailability and safety of ribupatide, a novel dual GLP-1/GIP receptor agonist: Phase 1, randomised, single-dose crossover study results (EASD 2026) - P1 | "Ribupatide injection to the upper arm or thigh resulted in plasma exposures comparable to those observed following abdominal injection. Ribupatide was generally well-tolerated regardless of injection site; no new safety signals were identified."

Clinical • P1 data • Metabolic Disorders • Obesity

A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Kailera

New P1 trial • Chronic Kidney Disease • Genetic Disorders • Nephrology • Obesity • Renal Disease

Efficacy and safety of ribupatide (HRS9531) in participants with obesity and polyendocrine metabolic ovarian syndrome (PMOS): a multicentre, randomised, double-blind, Phase 2 trial (EASD 2026) - P2 | "Ribupatide 1-4 mg significantly reduced body weight in a dose-dependent manner and improved menstrual frequency, regularity, insulin resistance, and hyperandrogenism in Chinese women with obesity and PMOS, with a favorable safety profile."

Clinical • Late-breaking abstract • P2 data • Metabolic Disorders • Obesity

A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Anticipated Key Milestones (GlobeNewswire) - "(i) Ribupatide injection: U.S. Phase 2b high dose obesity data anticipated in mid-2027; global Phase 3 obesity data anticipated in 2028; (ii) Ribupatide oral: Global Phase 3 obesity trial initiations anticipated in the first half of 2027."

New P3 trial • P2 data • P3 data • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=884 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes (clinicaltrials.gov) - P3 | N=2340 | Recruiting | Sponsor: Kailera | N=1800 ➔ 2340

Enrollment change • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes (clinicaltrials.gov) - P3 | N=1156 | Recruiting | Sponsor: Kailera | N=1700 ➔ 1156

Enrollment change • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis (clinicaltrials.gov) - P3 | N=382 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P3 trial • Genetic Disorders • Immunology • Obesity • Osteoarthritis • Rheumatology

Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: Kailera | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

HRS9531-302: the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes? Inadequately Controlled With Diet and Exercise Alone (clinicaltrials.gov) - P3 | N=218 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: May 2025 ➔ Jan 2026

Trial completion • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase I study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-5817 injection in healthy or obese subjects with single and multiple doses. (clinicaltrials.gov) - P1 | N=146 | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | N=92 ➔ 146

Enrollment change • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=102 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

HRS9531-105: A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P2 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Phase 1, Randomized, Double-Blind, Single-Ascending Dose Study of KAI-9531, a Novel Dual GLP-1/GIP Receptor Agonist in Development for People Living with Overweight/Obesity (ADA 2026) - "KAI-9531 was generally well tolerated after a single dose without titration, both in participants of Asian and non-Asian heritage. Similar exposure to KAI-9531 was observed between the two groups once adjusted for baseline BW. By EOS, KAI-9531 reduced BW both dose-dependently and compared with PBO, with no differences observed between Asian and non-Asian participants."

Clinical • P1 data • Metabolic Disorders • Obesity

Efficacy and Safety of the GlP-1/GIP Dual Agonist HRS9531 in Overweight/Obese Chinese Patients with Polycystic Ovary Syndrome (ADA 2026) - "HRS9531 significantly reduced weight loss in overweight/obese patients with PCOS, and showed potential to improving menstrual frequency and regularity."

Clinical • Metabolic Disorders • Obesity

A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease (clinicaltrials.gov) - P3 | N=9262 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Atherosclerosis • Cardiovascular

Phase 1 Single Ascending Dose (SAD) Clinical Trial of Ribupatide Injection (GlobeNewswire) - "Hengrui Pharma and Kailera Therapeutics present ribupatide clinical data at ADA 2026....The trial enrolled 49 participants of which 55% were female, with a mean baseline body weight and BMI of 80 kg (176 lbs.) and 27.6 kg/mg2, respectively....Ribupatide injection demonstrated a safety and tolerability profile similar in participants of both Asian and non-Asian descent....Ribupatide injection reduced body weight in a dose-dependent manner, with no differences observed in body weight reduction between non-Asian and Asian participants. Participants administered a single dose of ribupatide injection achieved a mean weight loss of 1.4 (1 mg) to 5.5 % (3 mg) from baseline at Day 29 compared to 0.4% with placebo."

P1 data • Obesity

A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders

Ribupatide injection (KAI-9531), GLP-1/GIP receptor dual agonist (GlobeNewswire) - "The program encompasses three double-blind, randomized, placebo-controlled Phase 3 trials (KaiNETIC-1, KaiNETIC-2, and KaiNETIC-3) evaluating once-weekly ribupatide injection doses of up to 10 mg over 76 weeks in adults living with obesity or overweight. Data is anticipated in 2028...The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 250 participants with a BMI of 35 or greater and no type 2 diabetes (T2D). Participants will receive either placebo or doses up to 20 mg of ribupatide injection administered over a period of 48 weeks. Data is anticipated in 2027."

P2b data • P3 data • Trial status • Obesity

Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes (clinicaltrials.gov) - P2 | N=250 | Enrolling by invitation | Sponsor: Kailera | Recruiting ➔ Enrolling by invitation

Enrollment status • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity