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KAI-7535 for Obesity or Overweight with Weight-Related Comorbidities

This study is testing an oral tablet called KAI-7535 to see how well it helps adults living with obesity or overweight lose weight. You might be able to join if you are between 18 and 75 years old and have obesity (BMI of 30 or higher) or are overweight (BMI of 27 or higher) with at least one weight-related health issue like high blood pressure or sleep apnea. If you have type 2 diabetes, you might also be eligible if your BMI is 27 or higher. The main goal is to see the percentage of body weight change after 44 weeks for participants without diabetes. The study will also look at safety and other weight-related changes. This study is currently recruiting about 320 participants.

Study design
This is an interventional study comparing KAI-7535 to a placebo (an inactive pill). It plans to include about 320 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be evaluated for body weight changes at Week 44.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07497880

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Kailera
~320 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:KAI-7535Placebo

At a glance

Recruiting sites
36 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Measured over Baseline, Week 44

Conditions

Obesity
Overweight

Explore related trials

ObesityOverweightType 2 Diabetes Mellitus

Where it's being run

36 sites across 17 states
Texas10
Florida4
California3
New South Wales3
Arizona2
Illinois2
Missouri2
Connecticut1

Who to contact

Kailera Therapeutics, Inc.
[email protected]
1-781-317-0291
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes MellitusBaseline, Week 44