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

January 28, 2026 updated by: Kailera

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KAI-7535: Morning Dosing, Fed
Participants will receive KAI-7535 in the morning following a meal on dosing days.
Drug: KAI-7535
Oral tablets.
Experimental: KAI-7535: Morning Dosing, Fasted
Participants will receive KAI-7535 in the morning following an overnight fast on dosing days.
Drug: KAI-7535
Oral tablets.
Experimental: KAI-7535: Evening Dosing
Participants will receive KAI-7535 in the evening on dosing days.
Drug: KAI-7535
Oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Maximum Observed Concentration (Tmax) of KAI-7535
Time Frame: Pre-dose and up to 60 hours post-dose
Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535
Time Frame: Pre-dose and up to 60 hours post-dose
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
Time Frame: Pre-dose and up to 60 hours post-dose
Pre-dose and up to 60 hours post-dose
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
Pre-dose and up to 60 hours post-dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kailera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Actual)

January 26, 2026

Study Completion (Actual)

January 26, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K7535-1709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on KAI-7535

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe