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

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

  • Obesity
  • Overweight

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
Lincoln, California 95648

Kailera Clinical Site
Kenner, Louisiana 70065

More Details

Status
Recruiting
Sponsor
Kailera

Study Contact

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