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Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
NCT07284901 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07284901
The ClinicalTrials.gov registry entry for NCT07284901 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kailera, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07284901 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, North Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07284901?
The interventions under investigation include: Placebo (DRUG), KAI-9531 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07284901?
This trial is sponsored by Kailera, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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