Recruiting

Phase 2

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

Sponsor:

Kailera

Code:

NCT07497880

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KAI-7535

Placebo

Study Details

Brief summary:

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

Study ID

NCT07497880

Start date

Apr 6, 2026

Status verified date

Jul, 2026

Completion date

Jul 7, 2027

Anticipated

Primary completion date

Jul 7, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KAI-7535: Dose Schedule 1

Participants will receive KAI-7535 once daily.

experimental: KAI-7535: Dose Schedule 2

Participants will receive KAI-7535 once daily.

experimental: KAI-7535: Dose Schedule 3

Participants will receive KAI-7535 once daily.

experimental: KAI-7535: Dose Schedule 4

Participants will receive KAI-7535 once daily.

placebo comparator: Placebo

Participants will receive placebo matched to KAI-7535 once daily.

Interventions

KAI-7535

Oral tablets

Placebo

Oral tablets

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kailera Therapeutics, Inc.

1-781-317-0291 info-clinicalstudies@kailera.com

Locations

Kailera Clinical Site

Recruiting

Chandler, Arizona, United States, 85225

Kailera Clinical Site

Recruiting

Phoenix, Arizona, United States, 85044

Kailera Clinical Site

Recruiting

Irvine, California, United States, 92614

Kailera Clinical Site

Recruiting

Lincoln, California, United States, 95648

Kailera Clinical Site

Recruiting

Northridge, California, United States, 91325

Kailera Clinical Site

Recruiting

Hamden, Connecticut, United States, 06517

Kailera Clinical Site

Recruiting

Jacksonville, Florida, United States, 32256

Kailera Clinical Site

Recruiting

Jupiter, Florida, United States, 33458

Kailera Clinical Site

Recruiting

Palm Springs, Florida, United States, 33461

Kailera Clinical Site

Recruiting

Pembroke Pines, Florida, United States, 33024

Kailera Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Kailera Clinical Site

Recruiting

Chicago, Illinois, United States, 60640

Kailera Clinical Site

Recruiting

Skokie, Illinois, United States, 60077

Kailera Clinical Site

Recruiting

South Bend, Indiana, United States, 46617

Kailera Clinical Site

Recruiting

Kenner, Louisiana, United States, 70065

Kailera Clinical Site

Recruiting

Garden City, Michigan, United States, 48135

Kailera Clinical Site

Recruiting

Jefferson City, Missouri, United States, 65109

Kailera Clinical Site

Recruiting

Kansas City, Missouri, United States, 64151

Kailera Clinical Site

Recruiting

Spartanburg, South Carolina, United States, 29303

Kailera Clinical Site

Recruiting

Knoxville, Tennessee, United States, 37909

Kailera Clinical Site

Recruiting

Austin, Texas, United States, 78705

Kailera Clinical Site

Recruiting

Austin, Texas, United States, 78757

Kailera Clinical Site

Recruiting

Brownsville, Texas, United States, 78520

Kailera Clinical Site

Recruiting

Farmers Branch, Texas, United States, 75234

Kailera Clinical Site

Recruiting

Fort Worth, Texas, United States, 76135

Kailera Clinical Site

Recruiting

Mesquite, Texas, United States, 75149

Kailera Clinical Site

Recruiting

San Antonio, Texas, United States, 78222

Kailera Clinical Site

Recruiting

San Antonio, Texas, United States, 78229

Kailera Clinical Site

Recruiting

San Antonio, Texas, United States, 78240

Kailera Clinical Site

Recruiting

Sugar Land, Texas, United States, 77479

Kailera Clinical Site

Recruiting

Sandy City, Utah, United States, 84093

More Information

Sponsor

Kailera

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

Obesity
Overweight
Glucagon-like peptide-1
GLP-1
KAI-7535
Diabetes
Oral

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kailera on 2026-07-28.