Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

June 4, 2026 updated by: Kailera

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Recruiting
        • Kailera Clinical Site
    • California
      • Irvine, California, United States, 92614
        • Recruiting
        • Kailera Clinical Site
      • Lincoln, California, United States, 95648
        • Recruiting
        • Kailera Clinical Site
      • Northridge, California, United States, 91325
        • Recruiting
        • Kailera Clinical Site
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Recruiting
        • Kailera Clinical Site
    • Florida
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Kailera Clinical Site
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Kailera Clinical Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Kailera Clinical Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Kailera Clinical Site
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Recruiting
        • Kailera Clinical Site
    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • Recruiting
        • Kailera Clinical Site
    • Michigan
      • Garden City, Michigan, United States, 48135
        • Recruiting
        • Kailera Clinical Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Kailera Clinical Site
      • Kansas City, Missouri, United States, 64151
        • Recruiting
        • Kailera Clinical Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Kailera Clinical Site
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • Kailera Clinical Site
      • Brownsville, Texas, United States, 78520
        • Recruiting
        • Kailera Clinical Site
      • Farmers Branch, Texas, United States, 75234
        • Recruiting
        • Kailera Clinical Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Kailera Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m^2) or BMI ≥27 kg/m^2 and a previous diagnosis of at least 1 of the following:

    • Hypertension
    • Dyslipidemia
    • Obstructive sleep apnea
    • Cardiovascular disease

  • For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m^2 only:

    • Diagnosis of type 2 diabetes mellitus
    • On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening

Key Exclusion Criteria:

  • For participants without diabetes:

    • Laboratory evidence of diabetes
    • Taking a concomitant medication for the indication of glycemic control

  • For participants living with type 2 diabetes mellitus only:

    • History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
    • History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
    • History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
  • Started medications that may cause significant weight change within 3 months prior to screening, including 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 carcinoma
  • 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 or other severe psychiatric disorder
  • Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KAI-7535: Dose Schedule 1
Participants will receive KAI-7535 once daily.
Drug: KAI-7535
Oral tablets
Experimental: KAI-7535: Dose Schedule 2
Participants will receive KAI-7535 once daily.
Drug: KAI-7535
Oral tablets
Experimental: KAI-7535: Dose Schedule 3
Participants will receive KAI-7535 once daily.
Drug: KAI-7535
Oral tablets
Experimental: KAI-7535: Dose Schedule 4
Participants will receive KAI-7535 once daily.
Drug: KAI-7535
Oral tablets
Placebo Comparator: Placebo
Participants will receive placebo matched to KAI-7535 once daily.
Drug: Placebo
Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time Frame: Baseline, Week 44
Baseline, Week 44

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time Frame: Baseline, Week 44
Baseline, Week 44
Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus
Time Frame: Baseline, Week 44
Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus
Time Frame: Week 44
Week 44
Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time Frame: Baseline, Week 44
Baseline, Week 44
Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time Frame: Baseline, Week 44
Baseline, Week 44
Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time Frame: Baseline, Week 44
Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Living with Type 2 Diabetes Mellitus
Time Frame: Week 44
Week 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kailera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2026

Primary Completion (Estimated)

July 7, 2027

Study Completion (Estimated)

July 7, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K7535-2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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