GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2

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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Lead sponsor

Kailera

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

320

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body Weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07497880

Org study IDK7535-2101

Timeline

Milestones

Study first posted2026-03-27actual

Study start2026-04-06actual

Last update posted2026-05-28actual

Primary completion2027-07-07estimated

Study completion2027-07-07estimated

Assets

Investigational agents

KAI-7535 / HRS-7535

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

8 endpoints

Primary/protocol endpoint

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

Time frame:Baseline, Week 44

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 44

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 44

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus

Time frame:Week 44

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 44

percent change from baseline, improvement

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 44

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.