Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Purpose
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- BMI ≥35 kilograms per square meter (kg/m^2). - 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 the 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, glucagon-like peptide-1 receptor (GLP-1R) 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)
- Masking Description
- The participant and investigator will be blinded for participants randomized to KAI-9531 or placebo until the study is complete. Semaglutide will be provided open-label.
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. |
|
|
Active Comparator Semaglutide |
Participants will receive semaglutide once weekly. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to KAI-9531 once weekly. |
|
Recruiting Locations
Kailera Clinical Site
Glendale, Arizona 85308
Glendale, Arizona 85308
Kailera Clinical Site
Phoenix, Arizona 85012
Phoenix, Arizona 85012
Kailera Clinical Site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Kailera Clinical Site
Northridge, California 91325
Northridge, California 91325
Kailera Clinical Site
Oceanside, California 92058
Oceanside, California 92058
Kailera Clinical Site
Hamden, Connecticut 06517
Hamden, Connecticut 06517
Kailera Clinical Site
Stamford, Connecticut 06905
Stamford, Connecticut 06905
Kailera Clinical Site
Orange City, Florida 32763
Orange City, Florida 32763
Kailera Clinical Site
Albany, Georgia 31707
Albany, Georgia 31707
Kailera Clinical Site
Chicago, Illinois 60640
Chicago, Illinois 60640
Kailera Clinical Site
Skokie, Illinois 60077
Skokie, Illinois 60077
Kailera Clinical Site
Newton, Kansas 67114
Newton, Kansas 67114
Kailera Clinical Site
Shreveport, Louisiana 71105
Shreveport, Louisiana 71105
Kailera Clinical Site
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Kailera Clinical Site
Missoula, Montana 59804
Missoula, Montana 59804
Kailera Clinical Site
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Kailera Clinical Site
Albany, New York 12203
Albany, New York 12203
Kailera Clinical Site
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Kailera Clinical Site
Morrisville, North Carolina 27560
Morrisville, North Carolina 27560
Kailera Clinical Site
Norman, Oklahoma 73069
Norman, Oklahoma 73069
Kailera Clinical Site
East Greenwich, Rhode Island 02818
East Greenwich, Rhode Island 02818
Kailera Clinical Site
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Kailera Clinical Site
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Kailera Clinical Site
Brownsville, Texas 78526
Brownsville, Texas 78526
Kailera Clinical Site
San Antonio, Texas 78229
San Antonio, Texas 78229
Kailera Clinical Site
Manassas, Virginia 20110
Manassas, Virginia 20110
Kailera Clinical Site
Richmond, Virginia 23236
Richmond, Virginia 23236
More Details
- Status
- Recruiting
- Sponsor
- Kailera