Current partner codePEPTIDESDE
NCT07497880·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

320

Locations

36

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

KAI-7535

Oral tablets

DRUG

Placebo

Oral tablets

Timeline

From registration to results.

  1. First posted

    Mar 27, 2026

  2. Study start

    Apr 6, 2026

  3. Primary completion

    Jul 7, 2027

  4. Study completion

    Jul 7, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 28, 2026

Outcomes

What the study measures.

Primary outcomes

Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus

Time frame · Baseline, Week 44

Secondary outcomes

Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus

Time frame · Baseline, Week 44

Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus

Time frame · 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

Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus

Time frame · 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

Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus

Time frame · 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

36 registered sites.

Australia · United States. Showing up to 24 locations stored in the fast local snapshot.

Kailera Clinical Site

Chandler, Arizona, United States

Kailera Clinical Site

Phoenix, Arizona, United States

Kailera Clinical Site

Irvine, California, United States

Kailera Clinical Site

Lincoln, California, United States

Kailera Clinical Site

Northridge, California, United States

Kailera Clinical Site

Hamden, Connecticut, United States

Kailera Clinical Site

Jacksonville, Florida, United States

Kailera Clinical Site

Jupiter, Florida, United States

Kailera Clinical Site

Palm Springs, Florida, United States

Kailera Clinical Site

Pembroke Pines, Florida, United States

Kailera Clinical Site

Decatur, Georgia, United States

Kailera Clinical Site

Chicago, Illinois, United States

Kailera Clinical Site

Skokie, Illinois, United States

Kailera Clinical Site

South Bend, Indiana, United States

Kailera Clinical Site

Kenner, Louisiana, United States

Kailera Clinical Site

Garden City, Michigan, United States

Kailera Clinical Site

Jefferson City, Missouri, United States

Kailera Clinical Site

Kansas City, Missouri, United States

Kailera Clinical Site

Spartanburg, South Carolina, United States

Kailera Clinical Site

Knoxville, Tennessee, United States

Kailera Clinical Site

Austin, Texas, United States

Kailera Clinical Site

Austin, Texas, United States

Kailera Clinical Site

Brownsville, Texas, United States

Kailera Clinical Site

Farmers Branch, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Glucagon.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.