Actively Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Weekly KAI-9531 Injections in Adults with Obesity or Overweight and Weight-Related Health Conditions Without Diabetes
Led by Kailera · Updated on 2026-06-08
1800
Participants Needed
37
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who have weight-related health conditions but do not have diabetes. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare changes in body weight between different doses of KAI-9531 and placebo over time. Participants will be randomly assigned to receive one of four different doses of KAI-9531 or a matching placebo once a week. The study treatment is administered by injection under the skin. The main comparison focuses on the percent change in body weight at week 76, with doses 3 and 4 compared specifically to placebo. Secondary measures include changes in waist circumference, blood pressure, cholesterol levels, quality of life scores related to weight, and other health indicators. During the study, participants will undergo regular assessments including weight measurements, blood tests, questionnaires about eating behavior and quality of life, and monitoring for any side effects. The study will track body weight changes, metabolic markers, and the presence of antibodies against the study drug up to week 80. The total participation time includes the treatment and follow-up periods lasting over a year and a half, allowing researchers to evaluate both efficacy and safety over the long term.
CONDITIONS
Brief Title
Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Body mass index (BMI) of 30 kg/m² or higher, or BMI of 27 kg/m² or higher with at least one of these conditions: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- History of at least one unsuccessful attempt to lose weight with diet and exercise within the past 6 months
You will not qualify if you...
- Current diagnosis or history of diabetes mellitus
- Use of medications in the past 3 months that may cause significant weight gain, such as tricyclic antidepressants, atypical antipsychotics, or mood stabilizers
- Unstable weight with more than 5% change in body weight within the past 3 months
- 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 significant gastric emptying issues or chronic use of medications affecting gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable major depressive disorder or other severe psychiatric disorders
- Treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, or related drugs within 3 months prior to screening
Research Team
K
Kailera Therapeutics, Inc.
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