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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07294898

Enrollment

Registered

2025-12-19

Start date

2025-12-15

Completion date

2026-01-26

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Obesity, Overweight, Glucagon-like peptide-1, GLP-1, KAI-7535

Brief summary

The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight.

Interventions

DRUGKAI-7535

Oral tablets.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
Time to Maximum Observed Concentration (Tmax) of KAI-7535	Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535	Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535	Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535	Pre-dose and up to 60 hours post-dose

Secondary

Measure	Time frame
Number of Participants with a Treatment-emergent Adverse Event (TEAE)	Day 1 up to Day 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026