Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

NCT07284979 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: K9531-31072025-523511-11-00
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 32

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; KAI-9531; Glucagon-like peptide-1; GLP-1; Semaglutide; Glucose-dependent Insulinotropic Peptide; GIP

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Weight at Week 76

  Baseline, Week 76

Secondary Outcomes (23)

• Percentage of Participants with ≥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

• Percentage of Participants with ≥5% Reduction in Body Weight

  Baseline, Week 76

• Change From Baseline in Systolic Blood Pressure (SBP)

  Baseline, Week 76

Study Arms (4)

KAI-9531: Dose 1

EXPERIMENTAL

Participants will receive Dose 1 of KAI-9531 once weekly.

Drug: KAI-9531

KAI-9531: Dose 2

EXPERIMENTAL

Participants will receive Dose 2 of KAI-9531 once weekly.

Drug: KAI-9531

Semaglutide

ACTIVE COMPARATOR

Participants will receive semaglutide once weekly.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to KAI-9531 once weekly.

Drug: Placebo

Interventions

KAI-9531 DRUG

SC Injection

KAI-9531: Dose 1; KAI-9531: Dose 2

Semaglutide DRUG

SC Injection

Also known as: Wegovy

Semaglutide

Placebo DRUG

SC Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kailera: lead

Study Sites (32)

Kailera Clinical Site

Glendale, Arizona, 85308, United States

RECRUITING

Kailera Clinical Site

Phoenix, Arizona, 85012, United States

RECRUITING

Kailera Clinical Site

Little Rock, Arkansas, 72205, United States

RECRUITING

Kailera Clinical Site

Northridge, California, 91325, United States

RECRUITING

Kailera Clinical Site

Oceanside, California, 92058, United States

RECRUITING

Kailera Clinical Site

Hamden, Connecticut, 06517, United States

RECRUITING

Kailera Clinical Site

Stamford, Connecticut, 06905, United States

RECRUITING

Kailera Clinical Site

Orange City, Florida, 32763, United States

RECRUITING

Kailera Clinical Site

Albany, Georgia, 31707, United States

RECRUITING

Kailera Clinical Site

Chicago, Illinois, 60640, United States

RECRUITING

Kailera Clinical Site

Newton, Kansas, 67114, United States

RECRUITING

Kailera Clinical Site

Shreveport, Louisiana, 71105, United States

RECRUITING

Kailera Clinical Site

Farmington Hills, Michigan, 48334, United States

RECRUITING

Kailera Clinical Site

Missoula, Montana, 59804, United States

RECRUITING

Kailera Clinical Site

Las Vegas, Nevada, 89148, United States

RECRUITING

Kailera Clinical Site

Albany, New York, 12203, United States

RECRUITING

Kailera Clinical Site

Morehead City, North Carolina, 28557, United States

RECRUITING

Kailera Clinical Site

Norman, Oklahoma, 73069, United States

RECRUITING

Kailera Clinical Site

East Greenwich, Rhode Island, 02818, United States

RECRUITING

Kailera Clinical Site

North Charleston, South Carolina, 29405, United States

RECRUITING

Kailera Clinical Site

Spartanburg, South Carolina, 29303, United States

RECRUITING

Kailera Clinical Site

Brownsville, Texas, 78526, United States

RECRUITING

Kailera Clinical Site

San Antonio, Texas, 78229, United States

RECRUITING

Kailera Clinical Site

Manassas, Virginia, 20110, United States

RECRUITING

Kailera Clinical Site

Richmond, Virginia, 23236, United States

RECRUITING

Kailera Clinical Site

Bruce, Australian Capital Territory, 2617, Australia

RECRUITING

Kailera Clinical Site

Blacktown, New South Wales, 2148, Australia

RECRUITING

Kailera Clinical Site

Kanwal, New South Wales, 2259, Australia

RECRUITING

Kailera Clinical Site

Herston, Queensland, 4006, Australia

RECRUITING

Kailera Clinical Site

Morayfield, Queensland, 4506, Australia

RECRUITING

Kailera Clinical Site

South Brisbane, Queensland, 4101, Australia

RECRUITING

Kailera Clinical Site

Camberwell, Victoria, 3124, Australia

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kailera Therapeutics, Inc.

CONTACT

781-317-0291; info-clinicalstudies@kailera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): April 17, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); US (25)