Ribupatide for Obesity and Diabetes Study

This study is looking at how safe and effective an investigational medicine called Ribupatide is for people living with obesity or overweight and type 2 diabetes. Ribupatide is given as a shot under the skin once a week. We are comparing Ribupatide to a placebo (an inactive substance) to see if it helps with weight loss and improves blood sugar control (measured by HbA1c, a test that shows your average blood sugar over 2-3 months). You might be able to join if you have type 2 diabetes, a BMI of 27 or higher, and are currently on stable diabetes treatment or are newly diagnosed with specific HbA1c levels. The study aims to enroll 1156 participants, but its current status is unclear.

Study design
This is an interventional study comparing Ribupatide to a placebo. It plans to enroll 1156 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your body weight and HbA1c will be measured at the beginning of the study and again at Week 76.

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NCT07284901

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Kailera
~1,156 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:RibupatidePlacebo

At a glance

Recruiting sites
114 of 116 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Measured over Baseline, Week 76
+1 more outcome measured
Obesity With Diabetes
Overweight With Diabetes
116 sites across 73 states
Florida6
New South Wales6
California5
Texas4
Buenos Aires4
Auckland4
Czechia3
New Zealand3
  • Medical Director · STUDY_DIRECTOR · Kailera Therapeutics, Inc.

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Eligibility criteria

Inclusion

Diagnosis of type 2 diabetes mellitus (T2DM).
Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.
BMI ≥27 kg/m\^2.
History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Exclusion

Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes 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 within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine.
Unstable weight defined as self-reported change in body weight exceeding 5% 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.
Known clinically significant gastric emptying abnormality or chronic treatment with medications that directly affect gastrointestinal (GI) motility if taken for \>30 days continually within 3 months prior to Screening.
History of suicide attempt.
History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.
  • Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76Baseline, Week 76
  • Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76Baseline, Week 76