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NCT07284901 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
A Phase 3 study of Obesity With Diabetes and Overweight With Diabetes, sponsored by Kailera.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,700
- Enrollment target
- 20
- Study locations
NCT07284901: Recruiting Phase 3 study of Obesity With Diabetes and Overweight With Diabetes, sponsored by Kailera.
NCT07284901 is a Phase 3 study of Obesity With Diabetes and Overweight With Diabetes that is actively recruiting participants, run by Kailera. The registered enrollment target is 1,700 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07284901, a Phase 3 study of Obesity With Diabetes and Overweight With Diabetes, is actively recruiting participants, sponsored by Kailera.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,700 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG KAI-9531
Study Locations (20)
California
- Kailera Clinical Site - Escondido
- Kailera Clinical Site - Northridge
- Kailera Clinical Site - Oceanside
North Carolina
- Kailera Clinical Site - Greensboro
- Kailera Clinical Site - Morehead City
Texas
- Kailera Clinical Site - DeSoto
- Kailera Clinical Site - Tomball
Alabama
- Kailera Clinical Site - Cullman
Arizona
- Kailera Clinical Site - Phoenix
Arkansas
- Kailera Clinical Site - Little Rock
Connecticut
- Kailera Clinical Site - Stamford
Florida
- Kailera Clinical Site - Jupiter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,700 participants |
| Start Date | 2026-01-12 |
| Est. Completion | 2028-04-24 |
| Phase | Phase 3 |
What NCT07284901 shows while recruiting
NCT07284901 is an interventional study that assigns participants to a tested intervention. Its 1,700 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (120% higher).
The record links to 2 conditions, with Obesity With Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07284901 names 20 study sites across 16 states, led by California, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT07284901 about?
NCT07284901 is a clinical study titled "Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes". The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
What is the current status of trial NCT07284901?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,700 participants. The study started on 2026-01-12. Estimated completion is 2028-04-24.
What conditions does trial NCT07284901 study?
This clinical trial studies the following conditions: Obesity With Diabetes, Overweight With Diabetes.
What interventions are being tested in trial NCT07284901?
The interventions under investigation include: Placebo (DRUG), KAI-9531 (DRUG).
Who is sponsoring clinical trial NCT07284901?
This trial is sponsored by Kailera, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07284901 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07284901's enrollment target sits among peer trials
1,700 132nd of 2000 higher than 1,868 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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