About this data Sourced primarily from ClinicalTrials.gov — a listing isn't proof of safety or FDA approval.

Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.

Phase 3

Ribupatide

KAI-9531 / HRS9531

Company: Kailera Therapeutics
Mechanism: dual GLP-1/GIP
Route: Oral & injectable
Recruiting trials: 13 recruiting

21.2% Absolute change weight loss · 32 weeks · Adults with obesity · Phase 2 obesity trial (injectable)

Next milestone: Injectable Phase 2b high-dose data (2027-H1, estimated)

Find a Clinical Trial Near Me

13 recruiting studies currently listed on ClinicalTrials.gov.

Data source: ClinicalTrials.gov · trial data as of Sep 11, 2026

Trial details

Recruiting NCT NCT06974851

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 140 participants Est. completion 2026-12 1 site Stand-alone

Obstructive sleep apnea
View official trial listing →
Recruiting NCT NCT06994650

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 140 participants Est. completion 2027-01 1 site Stand-alone

Obstructive sleep apnea
View official trial listing →
Recruiting NCT NCT07060456

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 300 participants Est. completion 2027-03 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Recruiting NCT NCT07150962

Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 168 participants Est. completion 2026-09 1 site

Other conditions: Overweight or Obesity
View official trial listing →
Recruiting NCT NCT07284875

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Not yet reported Kailera 2340 participants Est. completion 2028-03 104 sites Stand-alone

Other conditions: Obesity, Overweight
View official trial listing →
Recruiting NCT NCT07284901

Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Not yet reported Kailera 1156 participants Est. completion 2028-04-24 167 sites Stand-alone

Other conditions: Obesity With Diabetes, Overweight With Diabetes
View official trial listing →
Recruiting NCT NCT07284979

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Not yet reported Kailera 1200 participants Est. completion 2028-04 59 sites Stand-alone

Other conditions: Obesity
View official trial listing →
Recruiting NCT NCT07540754

A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 24 participants Est. completion 2027-02 1 site Stand-alone

Other conditions: Diabetes Mellitus, Weight Loss
View official trial listing →
Recruiting NCT NCT07551492

A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 9262 participants Est. completion 2031-06-28 1 site Stand-alone

Cardiovascular disease
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Recruiting NCT NCT07559136

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 48 participants Est. completion 2027-03 1 site Stand-alone

Other conditions: Overweight and Obesity
View official trial listing →
Recruiting NCT NCT07599410

A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 240 participants Est. completion 2027-07 2 sites Stand-alone

Type 2 diabetes
View official trial listing →
Recruiting NCT NCT07660848

A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 160 participants Est. completion 2028-07 2 sites Stand-alone

MASH
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Recruiting NCT NCT07670884

A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 675 participants Est. completion 2027-11-30 2 sites Stand-alone

Other conditions: Chronic Management of Body Weight
View official trial listing →
Completed NCT NCT05152277

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 90 participants Est. completion 2022-08-24 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT05516966

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 64 participants Est. completion 2023-05-24 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT05881837

Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 249 participants Est. completion 2024-10-13 26 sites Stand-alone

Other conditions: Overweight or Obesity
View official trial listing →
Completed NCT NCT05893576

A Relative Bioavailability Study of HRS9531 in Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 50 participants Est. completion 2023-09-04 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT05966272

Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 199 participants Est. completion 2024-09-24 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT06054698

Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 61 participants Est. completion 2024-09-09 4 sites Stand-alone

Other conditions: Overweight or Obesity
View official trial listing →
Completed NCT NCT06246175

A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 32 participants Est. completion 2025-09-02 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Status unknown NCT NCT06287437

HRS9531 Controls Weight Regain in Obese Subjects

Not yet reported Shanghai Zhongshan Hospital 72 participants Est. completion 2025-12-31 1 site Stand-alone

Other conditions: Obesity
View official trial listing →
Active, not recruiting NCT NCT06391710

HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 203 participants Est. completion 2026-01 1 site Stand-alone

Heart failure
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Completed NCT NCT06396429

To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 567 participants Est. completion 2025-07-07 1 site Stand-alone

Other conditions: Overweight or Obesity
View official trial listing →
Completed NCT NCT06435676

A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 72 participants Est. completion 2024-10-08 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Not yet recruiting NCT NCT06506175

A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 100 participants Est. completion 2026-09 1 site Stand-alone

Type 2 diabetes Other conditions: Weight Management
View official trial listing →
Status unknown NCT NCT06565871

A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 108 participants Est. completion 2025-12 Stand-alone

Other conditions: Weight Management
View official trial listing →
Status unknown NCT NCT06595797

A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Polycystic Ovary Syndrome

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 144 participants Est. completion 2025-12 Stand-alone

Other conditions: Obese Subjects With Polycystic Ovary Syndrome (PCOS)
View official trial listing →
Completed NCT NCT06649344

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

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 884 participants Est. completion 2026-07-18 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT06650007

the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 218 participants Est. completion 2026-06-12 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT06654960

Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 20 participants Est. completion 2024-12-26 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT06723691

Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 57 participants Est. completion 2025-06-09 1 site Stand-alone

Type 2 diabetes
View official trial listing →
Completed NCT NCT06762600

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 102 participants Est. completion 2026-03-12 1 site Stand-alone

Other conditions: Overweight or Obesity
View official trial listing →
Completed NCT NCT06792955

The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 120 participants Est. completion 2025-06-06 1 site Stand-alone

Other conditions: Overweight/Obesity
View official trial listing →
Completed NCT NCT06841445

Efficacy and Safety of HRS9531 Tablet in Obese Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 166 participants Est. completion 2026-01-08 1 site Stand-alone

Other conditions: Chronic Management of Body Weight
View official trial listing →
Completed NCT NCT06855147

Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 7 participants Est. completion 2025-06-17 1 site Stand-alone

Type 2 diabetes Other conditions: Weight Loss
View official trial listing →
Completed NCT NCT07044401

A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices

Not yet reported Kailera 51 participants Est. completion 2025-11-13 1 site Stand-alone

Other conditions: Healthy Volunteers
View official trial listing →
Active, not recruiting NCT NCT07285902

A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 572 participants Est. completion 2027-03 2 sites Stand-alone

Other conditions: Obesity
View official trial listing →
Active, not recruiting NCT NCT07458269

Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Not yet reported Kailera 264 participants Est. completion 2027-06 35 sites Stand-alone

Other conditions: Obesity
View official trial listing →
Not yet recruiting NCT NCT07709910

A Trial of Ribupatide Injection in Participants With Obesity and Knee Osteoarthritis

Not yet reported Fujian Shengdi Pharmaceutical Co., Ltd. 382 participants Est. completion 2028-12 1 site Stand-alone

Osteoarthritis
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Not yet recruiting NCT NCT07793929

A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide

Not yet reported Kailera 32 participants Est. completion 2028-02-08 1 site Stand-alone

Other conditions: End Stage Renal Disease, Renal Impairment, Obesity, Overweight
View official trial listing →

Efficacy history

21.2%

Absolute change weight loss · 32 weeks

Adults with obesity

Trial: Phase 2 obesity trial (injectable) (Phase 2)

Source →

12.1%

Absolute change weight loss · 26 weeks

Adults with obesity, China

Trial: Phase 2 obesity trial (oral, China) (Phase 2)

Source →

Results from different trials are not directly comparable — populations, timepoints, and measurement methods differ between studies.

Safety

Not yet reported.

Sources

Also known as: Ribupatide, KAI-9531 / HRS9531, HRS9531, KAI-9531

Related On The Pen coverage

No related coverage yet.

This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.