Clinical Trials in the USA / NCT07458269
Active, not recruiting
Phase 2
Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
NCT07458269 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Obesity
Investigational drug(s) / intervention(s)
Ribupatide →Placebo
Ribupatide: SC Injection
Placebo: SC Injection
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Percent Change From Baseline in Body Weight at Week 48 — Baseline, Week 48
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Kailera Clinical Site | Mesa | Arizona | |
| Kailera Clinical Site | Sun City West | Arizona | |
| Kailera Clinical Site | Irvine | California | |
| Kailera Clinical Site | Lake Forest | California | |
| Kailera Clinical Site | Lomita | California | |
| Kailera Clinical Site | Long Beach | California | |
| Kailera Clinical Site | Montclair | California | |
| Kailera Clinical Site | Rolling Hills Estates | California | |
| Kailera Clinical Site | San Diego | California | |
| Kailera Clinical Site | Santa Ana | California | |
| Kailera Clinical Site | Van Nuys | California | |
| Kailera Clinical Site | DeLand | Florida | |
| Kailera Clinical Site | Orlando | Florida | |
| Kailera Clinical Site | Orlando | Florida | |
| Kailera Clinical Site | The Villages | Florida | |
| Kailera Clinical Site | Decatur | Georgia | |
| Kailera Clinical Site | Woodstock | Georgia | |
| Kailera Clinical Site | Morton | Illinois | |
| Kailera Clinical Site | Indianapolis | Indiana | |
| Kailera Clinical Site | Louisville | Kentucky | |
| Kailera Clinical Site | Rockville | Maryland | |
| Kailera Clinical Site | St Louis | Missouri | |
| Kailera Clinical Site | Lincoln | Nebraska | |
| Kailera Clinical Site | Omaha | Nebraska | |
| Kailera Clinical Site | East Syracuse | New York | |
| Kailera Clinical Site | Greensboro | North Carolina | |
| Kailera Clinical Site | Monroe | North Carolina | |
| Kailera Clinical Site | Raleigh | North Carolina | |
| Kailera Clinical Site | Greenville | South Carolina | |
| Kailera Clinical Site | Myrtle Beach | South Carolina | |
| Kailera Clinical Site | Knoxville | Tennessee | |
| Kailera Clinical Site | Memphis | Tennessee | |
| Kailera Clinical Site | Garland | Texas | |
| Kailera Clinical Site | San Antonio | Texas | |
| Kailera Clinical Site | Winchester | Virginia |
More Kailera trials in the USA
Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Active, not recruiting
Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Active, not recruiting
Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
Active, not recruiting
Other trials for the same condition
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
Active, not recruiting
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07458269 on ClinicalTrials.gov ↗ ← All trials in the USA