Clinical trial

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

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07458269

Active, not recruitingPhase 2Interventional

What this study is about

The primary objective of this study is to determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

Key Inclusion Criteria: * BMI ≥35 kilograms per meter squared (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma. * Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers. * 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 motility. * 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, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Treatments and study arms

Ribupatide

Drug

SC Injection

Placebo

Drug

SC Injection

Primary outcomes

Percent Change From Baseline in Body Weight at Week 48Baseline, Week 48

Study locations

35 locations were listed when this page was built. The first 40 are shown.

Kailera Clinical Site🇺🇸 DeLand, Florida, United States
Kailera Clinical Site🇺🇸 Decatur, Georgia, United States
Kailera Clinical Site🇺🇸 East Syracuse, New York, United States
Kailera Clinical Site🇺🇸 Garland, Texas, United States
Kailera Clinical Site🇺🇸 Greensboro, North Carolina, United States
Kailera Clinical Site🇺🇸 Greenville, South Carolina, United States
Kailera Clinical Site🇺🇸 Indianapolis, Indiana, United States
Kailera Clinical Site🇺🇸 Irvine, California, United States
Kailera Clinical Site🇺🇸 Knoxville, Tennessee, United States
Kailera Clinical Site🇺🇸 Lake Forest, California, United States
Kailera Clinical Site🇺🇸 Lincoln, Nebraska, United States
Kailera Clinical Site🇺🇸 Lomita, California, United States
Kailera Clinical Site🇺🇸 Long Beach, California, United States
Kailera Clinical Site🇺🇸 Louisville, Kentucky, United States
Kailera Clinical Site🇺🇸 Memphis, Tennessee, United States
Kailera Clinical Site🇺🇸 Mesa, Arizona, United States
Kailera Clinical Site🇺🇸 Monroe, North Carolina, United States
Kailera Clinical Site🇺🇸 Montclair, California, United States
Kailera Clinical Site🇺🇸 Morton, Illinois, United States
Kailera Clinical Site🇺🇸 Myrtle Beach, South Carolina, United States
Kailera Clinical Site🇺🇸 Omaha, Nebraska, United States
Kailera Clinical Site🇺🇸 Orlando, Florida, United States
Kailera Clinical Site🇺🇸 Orlando, Florida, United States
Kailera Clinical Site🇺🇸 Raleigh, North Carolina, United States
Kailera Clinical Site🇺🇸 Rockville, Maryland, United States
Kailera Clinical Site🇺🇸 Rolling Hills Estates, California, United States
Kailera Clinical Site🇺🇸 San Antonio, Texas, United States
Kailera Clinical Site🇺🇸 San Diego, California, United States
Kailera Clinical Site🇺🇸 Santa Ana, California, United States
Kailera Clinical Site🇺🇸 St Louis, Missouri, United States
Kailera Clinical Site🇺🇸 Sun City West, Arizona, United States
Kailera Clinical Site🇺🇸 The Villages, Florida, United States
Kailera Clinical Site🇺🇸 Van Nuys, California, United States
Kailera Clinical Site🇺🇸 Winchester, Virginia, United States
Kailera Clinical Site🇺🇸 Woodstock, Georgia, United States