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

Phase 3RecruitingNCT07284875

Kailera1,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,800

Conditions

Obesity Overweight

Interventions

KAI-9531DRUG

SC Injection

PlaceboDRUG

SC Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Kailera Clinical Site

Anniston, Alabama, United States

Outcomes

Primary Outcomes

Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame: Baseline, Week 76

Secondary Outcomes

Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame: Baseline, Week 76

Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

Time frame: Baseline, Week 76

Change From Baseline in Waist Circumference

Time frame: Baseline, Week 76

Change From Baseline in Absolute Body Weight

Time frame: Baseline, Week 76

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame: Baseline, Week 76

Percent Change From Baseline in Fasting Triglycerides

Time frame: Baseline, Week 76

Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol

Time frame: Baseline, Week 76

Percent Change From Baseline in Fasting Non-HDL-cholesterol

Time frame: 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

Time frame: Baseline, Week 76

Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight

Central Contacts

Kailera Therapeutics, Inc.

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.