GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Investigate the Effect of a Low-fat Meal and Evening Dosing on KAI-7535 in Participants Living With Obesity or Overweight

A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of a Low-Fat Meal and Evening Dosing on the Pharmacokinetics of KAI-7535 in Healthy Participants Living With Obesity or Overweight

Lead sponsor

Kailera

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 25-40•Healthy volunteers

Primary endpoints

•Cmax (Tmax) of KAI-7535•Cmax of KAI-7535•AUC From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535

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 IDNCT07294898

Org study IDK7535-1709

Timeline

Milestones

Study start2025-12-15actual

Study first posted2025-12-19actual

Primary completion2026-01-26actual

Study completion2026-01-26actual

Last update posted2026-01-29actual

Assets

Investigational agents

KAI-7535 / HRS-7535

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Key Inclusion Criteria:

•Body mass index (BMI) ≥25.0 and ≤40.0 kg/m^2.

•Medically healthy, as determined by prestudy medical history, and without clinically significant (CS) abnormalities.

Key Exclusion Criteria:

•Known hypersensitivity to study treatment or any study treatment ingredients.

•History or presence of CS cardiovascular, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Endpoints (5)

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.

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Time to Maximum Observed Concentration (Tmax) of KAI-7535

Time frame:Pre-dose and up to 60 hours post-dose

time to event, event

Primary/protocol endpoint

Maximum Observed Concentration (Cmax) of KAI-7535

Time frame:Pre-dose and up to 60 hours post-dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535

Time frame:Pre-dose and up to 60 hours post-dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535

Time frame:Pre-dose and up to 60 hours post-dose

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with a Treatment-emergent Adverse Event (TEAE)

Time frame:Day 1 up to Day 12

event count, event

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.