Clinical Trials in the USA / NCT07284875
Active, not recruiting
Phase 3
Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
NCT07284875 · tracked via the Priya Life Science USA tracker
Condition(s) studied
ObesityOverweight
Investigational drug(s) / intervention(s)
Ribupatide →Placebo
Ribupatide: SC Injection
Placebo: SC Injection
Study summary
The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Eligibility
Inclusion Criteria:
* BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
1. hypertension,
2. dyslipidemia,
3. obstructive sleep apnea, or
4. cardiovascular (CV) disease.
* 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 Criteria:
* Current diagnosis or history of diabetes mellitus.
* 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 motility.
* History of suicide attempt.
* History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
* Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Primary outcome measure(s)
- Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 — Baseline, Week 76
Trial sites (110)
| Facility | City | Region | Status |
|---|---|---|---|
| Kailera Clinical Site | Anniston | Alabama | |
| Kailera Clinical Site | Birmingham | Alabama | |
| Kailera Clinical Site | Cullman | Alabama | |
| Kailera Clinical Site | Sun City | Arizona | |
| Kailera Clinical Site | Escondido | California | |
| Kailera Clinical Site | Toluca Lake | California | |
| Kailera Clinical Site | Aurora | Colorado | |
| Kailera Clinical Site | Bridgeport | Connecticut | |
| Kailera Clinical Site | Jupiter | Florida | |
| Kailera Clinical Site | Lilburn | Georgia | |
| Kailera Clinical Site | Springfield | Illinois | |
| Kailera Clinical Site | Columbia | Maryland | |
| Kailera Clinical Site | Las Vegas | Nevada | |
| Kailera Clinical Site | Rochester | New York | |
| Kailera Clinical Site | Morehead City | North Carolina | |
| Kailera Clinical Site | Chickasha | Oklahoma | |
| Kailera Clinical Site | Mauldin | South Carolina | |
| Kailera Clinical Site | Chattanooga | Tennessee | |
| Kailera Clinical Site | Amarillo | Texas | |
| Kailera Clinical Site | Bellaire | Texas | |
| Kailera Clinical Site | DeSoto | Texas | |
| Kailera Clinical Site | Tomball | Texas | |
| Kailera Clinical Site | Salt Lake City | Utah | |
| Kailera Clinical Site | Danville | Virginia | |
| Kailera Clinical Site | La Plata | Buenos Aires | |
| Kailera Clinical Site #1 | San Nicolás de los Arroyos | Buenos Aires | |
| Kailera Clinical Site #2 | San Nicolás de los Arroyos | Buenos Aires | |
| Kailera Clinical Site #1 | Buenos Aires | Buenos Aires F.D. | |
| Kailera Clinical Site #2 | Buenos Aires | Buenos Aires F.D. | |
| Kailera Clinical Site | Buenos Aires | Buenos Aires F.D. | |
| Kailera Clinical Site | Buenos Aires | Buenos Aires F.D. | |
| Kailera Clinical Site | Godoy Cruz | Mendoza Province | |
| Kailera Clinical Site #1 | Rosario | Santa Fe Province | |
| Kailera Clinical Site #2 | Rosario | Santa Fe Province | |
| Kailera Clinical Site #3 | Rosario | Santa Fe Province | |
| Kailera Clinical Site | CABA | Argentina | |
| Kailera Clinical Site | Córdoba | Argentina | |
| Kailera Clinical Site | Charlestown | New South Wales | |
| Kailera Clinical Site | Sydney | New South Wales | |
| Kailera Clinical Site | Sydney | New South Wales |
+ 70 more sites — see the full list on the official registry below.
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 (KAI-9531) Administered Once Weekly in Participants Living With Obesity 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 NCT07284875 on ClinicalTrials.gov ↗ ← All trials in the USA