Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
Purpose
The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Conditions
- Obesity
- Overweight
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Exclusion Criteria
- Current diagnosis or history of diabetes mellitus. - 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. - 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental KAI-9531: Dose 1 |
Participants will receive Dose 1 of KAI-9531 once weekly. |
|
|
Experimental KAI-9531: Dose 2 |
Participants will receive Dose 2 of KAI-9531 once weekly. |
|
|
Experimental KAI-9531: Dose 3 |
Participants will receive Dose 3 of KAI-9531 once weekly. |
|
|
Experimental KAI-9531: Dose 4 |
Participants will receive Dose 4 of KAI-9531 once weekly. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to KAI-9531 once weekly. |
|
Recruiting Locations
Kailera Clinical Site
Anniston 4830198, Alabama 4829764 36207
Anniston 4830198, Alabama 4829764 36207
Kailera Clinical Site
Cullman 4057835, Alabama 4829764 35055
Cullman 4057835, Alabama 4829764 35055
Kailera Clinical Site
Sun City 5316201, Arizona 5551752 85351
Sun City 5316201, Arizona 5551752 85351
Kailera Clinical Site
Aurora 5412347, Colorado 5417618 80012
Aurora 5412347, Colorado 5417618 80012
Kailera Clinical Site
Bridgeport 5282804, Connecticut 4831725 06606
Bridgeport 5282804, Connecticut 4831725 06606
Kailera Clinical Site
Jupiter 4160610, Florida 4155751 33458
Jupiter 4160610, Florida 4155751 33458
Kailera Clinical Site
Lilburn 4205724, Georgia 4197000 30047
Lilburn 4205724, Georgia 4197000 30047
Kailera Clinical Site
Springfield 4250542, Illinois 4896861 62072
Springfield 4250542, Illinois 4896861 62072
Kailera Clinical Site
Columbia 4352053, Maryland 4361885 21045
Columbia 4352053, Maryland 4361885 21045
Kailera Clinical Site
Las Vegas 5506956, Nevada 5509151 89119
Las Vegas 5506956, Nevada 5509151 89119
Kailera Clinical Site
Rochester 5134086, New York 5128638 14609
Rochester 5134086, New York 5128638 14609
Kailera Clinical Site
Morehead City 4480153, North Carolina 4482348 28557
Morehead City 4480153, North Carolina 4482348 28557
Kailera Clinical Site
Chickasha 4533029, Oklahoma 4544379 73018
Chickasha 4533029, Oklahoma 4544379 73018
Kailera Clinical Site
Mauldin 4586523, South Carolina 4597040 29662
Mauldin 4586523, South Carolina 4597040 29662
Kailera Clinical Site
Chattanooga 4612862, Tennessee 4662168 37405
Chattanooga 4612862, Tennessee 4662168 37405
Kailera Clinical Site
Amarillo 5516233, Texas 4736286 79124
Amarillo 5516233, Texas 4736286 79124
Kailera Clinical Site
DeSoto 4685524, Texas 4736286 75115
DeSoto 4685524, Texas 4736286 75115
Kailera Clinical Site
Tomball 4737094, Texas 4736286 77375
Tomball 4737094, Texas 4736286 77375
Kailera Clinical Site
Salt Lake City 5780993, Utah 5549030 84124
Salt Lake City 5780993, Utah 5549030 84124
Kailera Clinical Site
Danville 4755280, Virginia 6254928 24541
Danville 4755280, Virginia 6254928 24541
More Details
- Status
- Recruiting
- Sponsor
- Kailera