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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Kailera Clinical Site
Chandler, Arizona 85225

Kailera Clinical Site
Irvine, California 92614

Kailera Clinical Site
Lincoln, California 95648

Kailera Clinical Site
Northridge, California 91325

Kailera Clinical Site
Hamden, Connecticut 06517

Kailera Clinical Site
Jacksonville, Florida 32256

Kailera Clinical Site
Jupiter, Florida 33458

Kailera Clinical Site
Pembroke Pines, Florida 33024

Kailera Clinical Site
Decatur, Georgia 30030

Kailera Clinical Site
Skokie, Illinois 60077

Kailera Clinical Site
South Bend, Indiana 46617

Kailera Clinical Site
Kenner, Louisiana 70065

Kailera Clinical Site
Garden City, Michigan 48135

Kailera Clinical Site
Jefferson City, Missouri 65109

Kailera Clinical Site
Kansas City, Missouri 64151

Kailera Clinical Site
Spartanburg, South Carolina 29303

Kailera Clinical Site
Knoxville, Tennessee 37909

Kailera Clinical Site
Austin, Texas 78757

Kailera Clinical Site
Brownsville, Texas 78520

Kailera Clinical Site
Farmers Branch, Texas 75234

Kailera Clinical Site
San Antonio, Texas 78222

Kailera Clinical Site
San Antonio, Texas 78229

Kailera Clinical Site
Sugar Land, Texas 77479

More Details

Status
Recruiting
Sponsor
Kailera

Study Contact

Kailera Therapeutics, Inc.
1-781-317-0291
info-clinicalstudies@kailera.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.