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Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes Phase 3 1,800

Recruiting
Clinical Trial NCT07284875 is designed to study Treatment for Obesity, Overweight. It is a Phase 3 interventional study that is recruiting, having started on December 18, 2025, with plans to enroll 1,800 participants. Led by Kailera, it is expected to complete by March 27, 2028. The latest data from ClinicalTrials.gov was last updated on March 2, 2026.
Brief Summary
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.
Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Conditions
ObesityOverweight
Other Study IDs
  • K9531-3103
  • 2025-523486-17-00 (EU Study (CTIS) Number)
NCT ID Number
NCT07284875
Start Date (Actual)
2025-12-18
Last Update Posted
2026-03-02
Completion Date (Estimated)
2028-03-27
Enrollment (Estimated)
1,800
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
Overweight
Obesity
KAI-9531
Glucagon-like Peptide-1
GLP-1
Glucose-dependent Insulinotropic Peptide
GIP
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalKAI-9531: Dose 1
Participants will receive Dose 1 of KAI-9531 once weekly.
KAI-9531
SC Injection
ExperimentalKAI-9531: Dose 2
Participants will receive Dose 2 of KAI-9531 once weekly.
KAI-9531
SC Injection
ExperimentalKAI-9531: Dose 3
Participants will receive Dose 3 of KAI-9531 once weekly.
KAI-9531
SC Injection
ExperimentalKAI-9531: Dose 4
Participants will receive Dose 4 of KAI-9531 once weekly.
KAI-9531
SC Injection
Placebo ComparatorPlacebo
Participants will receive placebo matched to KAI-9531 once weekly.
Placebo
SC Injection
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Baseline, Week 76
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Baseline, Week 76
Change From Baseline in Waist Circumference
Baseline, Week 76
Change From Baseline in Absolute Body Weight
Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Baseline, Week 76
Change From Baseline in BMI
Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Baseline, Week 76
Percent Change From Baseline in Total Cholesterol
Baseline, Week 76
Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol
Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Up to Week 80
Plasma Concentrations of KAI-9531
Up to Week 76
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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.

  • 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.

Kailera logoKailera
Study Central Contact
Contact: Kailera Therapeutics, Inc., 781-317-0291, [email protected]
22 Study Locations in 1 Countries

Alabama

Kailera Clinical Site, Anniston, Alabama, 36207, United States
Recruiting
Kailera Clinical Site, Cullman, Alabama, 35055, United States
Recruiting

Arizona

Kailera Clinical Site, Sun City, Arizona, 85351, United States
Recruiting

California

Kailera Clinical Site, Escondido, California, 92025, United States
Recruiting
Kailera Clinical Site, Toluca Lake, California, 91602, United States
Recruiting

Colorado

Kailera Clinical Site, Aurora, Colorado, 80012, United States
Recruiting

Connecticut

Kailera Clinical Site, Bridgeport, Connecticut, 06606, United States
Recruiting

Florida

Kailera Clinical Site, Jupiter, Florida, 33458, United States
Recruiting

Georgia

Kailera Clinical Site, Lilburn, Georgia, 30047, United States
Recruiting

Illinois

Kailera Clinical Site, Springfield, Illinois, 62072, United States
Recruiting

Maryland

Kailera Clinical Site, Columbia, Maryland, 21045, United States
Recruiting

Nevada

Kailera Clinical Site, Las Vegas, Nevada, 89119, United States
Recruiting

New York

Kailera Clinical Site, Rochester, New York, 14609, United States
Recruiting

North Carolina

Kailera Clinical Site, Morehead City, North Carolina, 28557, United States
Recruiting

Oklahoma

Kailera Clinical Site, Chickasha, Oklahoma, 73018, United States
Recruiting

South Carolina

Kailera Clinical Site, Mauldin, South Carolina, 29662, United States
Recruiting

Tennessee

Kailera Clinical Site, Chattanooga, Tennessee, 37405, United States
Recruiting

Texas

Kailera Clinical Site, Amarillo, Texas, 79124, United States
Recruiting
Kailera Clinical Site, DeSoto, Texas, 75115, United States
Recruiting
Kailera Clinical Site, Tomball, Texas, 77375, United States
Recruiting

Utah

Kailera Clinical Site, Salt Lake City, Utah, 84124, United States
Recruiting

Virginia

Kailera Clinical Site, Danville, Virginia, 24541, United States
Recruiting