Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

NCT07284901 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: K9531-31042025-523510-87-00
• Study Type: interventional
• Target: 1,700
• Locations: 3 countries
• Sites: 37

Brief Summary

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on:

• Percent change in body weight
• Change in hemoglobin A1c (HbA1c)

Conditions

Overweight With Diabetes; Obesity With Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

  Baseline, Week 76

• Doses 3 and 4 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76

  Baseline, Week 76

Secondary Outcomes (33)

• Doses 1 and 2 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

  Baseline, Week

• Doses 1 and 2 KAI-9531 Versus Placebo: Change From Baseline in HbA1c 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

Study Arms (5)

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

KAI-9531: Dose 3

EXPERIMENTAL

Participants will receive Dose 3 of KAI-9531 once weekly.

Drug: KAI-9531

KAI-9531: Dose 4

EXPERIMENTAL

Participants will receive Dose 4 of KAI-9531 once weekly.

Drug: KAI-9531

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; KAI-9531: Dose 3; KAI-9531: Dose 4

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:

• Diagnosis of type 2 diabetes mellitus (T2DM).
• Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitors.
• BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
• History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
• History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
• 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening.
• History of suicide attempt.
• History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
• Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.

Sponsors & Collaborators

• Kailera: lead

Study Sites (37)

Kailera Clinical Site

Cullman, Alabama, 35055, United States

RECRUITING

Kailera Clinical Site

Phoenix, Arizona, 85012, United States

RECRUITING

Kailera Clinical Site

Sun City, Arizona, 85351, United States

RECRUITING

Kailera Clinical Site

Little Rock, Arkansas, 72205, United States

RECRUITING

Kailera Clinical Site

Escondido, California, 92025, United States

RECRUITING

Kailera Clinical Site

Northridge, California, 91325, United States

RECRUITING

Kailera Clinical Site

Oceanside, California, 92058, United States

RECRUITING

Kailera Clinical Site

Toluca Lake, California, 91602, United States

RECRUITING

Kailera Clinical Site

Stamford, Connecticut, 06905, United States

RECRUITING

Kailera Clinical Site

Jupiter, Florida, 33458, United States

RECRUITING

Kailera Clinical Site

Orange City, Florida, 32763, United States

RECRUITING

Kailera Clinical Site

Lilburn, Georgia, 30047, United States

RECRUITING

Kailera Clinical Site

Springfield, Illinois, 62702, United States

RECRUITING

Kailera Clinical Site

Newton, Kansas, 67114, United States

RECRUITING

Kailera Clinical Site

Shreveport, Louisiana, 71105, United States

RECRUITING

Kailera Clinical Site

Columbia, Maryland, 21045, United States

RECRUITING

Kailera Clinical Site

Missoula, Montana, 59804, United States

RECRUITING

Kailera Clinical Site

Lincoln, Nebraska, 68516, 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

Greensboro, North Carolina, 27405, United States

RECRUITING

Kailera Clinical Site

Morehead City, North Carolina, 28557, United States

RECRUITING

Kailera Clinical Site

Chickasha, Oklahoma, 73018, United States

RECRUITING

Kailera Clinical Site

Spartanburg, South Carolina, 29303, United States

RECRUITING

Kailera Clinical Site

Chattanooga, Tennessee, 37405, United States

RECRUITING

Kailera Clinical Site

Amarillo, Texas, 79124, United States

RECRUITING

Kailera Clinical Site

Brownsville, Texas, 78526, United States

RECRUITING

Kailera Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Kailera Clinical Site

Tomball, Texas, 77375, United States

RECRUITING

Kailera Clinical Site

Salt Lake City, Utah, 84117, United States

RECRUITING

Kailera Clinical Site

Richmond, Virginia, 23236, United States

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2100, Australia

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2228, Australia

RECRUITING

Kailera Clinical Site

Wollongong, New South Wales, 2500, Australia

RECRUITING

Kailera Clinical Site

Camberwell, Victoria, 3124, Australia

RECRUITING

Kailera Clinical Site

Melbourne, Victoria, 3025, Australia

RECRUITING

Kailera Clinical Site

Nelson, 7011, New Zealand

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

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
• 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: January 12, 2026
• Primary Completion (Estimated): March 27, 2028
• Study Completion (Estimated): April 24, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); NZ (1); US (31)