What is ribupatide studying for obesity and diabetes?

Ribupatide is being studied to see if weekly injections can reduce body weight and improve blood sugar control in adults with obesity or overweight and type 2 diabetes. Researchers want to understand how different doses affect these outcomes compared to a placebo. This trial is sponsored by Kailera to evaluate the drug's safety and effects over time.

Who may be eligible for this obesity and diabetes clinical trial?

Adults aged 18 or older with type 2 diabetes and a body mass index (BMI) of at least 27 kg/m² may be eligible. Participants should have stable diabetes treatment for at least 3 months and a history of difficulty losing weight despite diet or exercise. People with certain other diabetes types or recent use of weight loss drugs are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity and diabetes clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07284901

Phase 3 Study of Weekly Ribupatide Injections for Adults with Obesity or Overweight and Type 2 Diabetes to Test Effectiveness and Safety

Led by Kailera · Updated on 2026-07-15

1156

Participants Needed

116

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of type 2 diabetes mellitus (T2DM).
Receiving stable therapy for T2DM for 3 months prior to screening, including diet/exercise alone or with oral medication except DPP-4 inhibitors.
Participants can be treatment naive if HbA1c is 6.5% to 7.5%, inclusive.
Body mass index (BMI) of 27 kg/m² or higher.
History of unsuccessful weight loss efforts with diet and/or exercise in the last 6 months.

You will not qualify if you...

Diagnosis or history of type 1 diabetes mellitus or other diabetes types except T2DM.
History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to screening.
History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to screening.
Started medications in last 3 months that may cause significant weight change (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers, phentermine).
Unstable weight with >5% change within 3 months prior to screening.
Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
Uncontrolled hypertension or unstable cardiovascular disease.
History of chronic or acute pancreatitis.
Clinically significant gastric emptying abnormality or chronic use of medications affecting gastrointestinal motility for >30 days within 3 months prior to screening.
History of suicide attempt.
Significant active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening.
Treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP agonists, glucagon receptor agonists, or other weight loss medications (besides diet and exercise) within 3 months prior to screening.

Research Team

Kailera Therapeutics, Inc.

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase 3 Study of Weekly Ribupatide Injections for Adults with Obesity or Overweight and Type 2 Diabetes to Test Effectiveness and Safety

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria