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

NCT ID: NCT07294898

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-01-26

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KAI-7535: Morning Dosing, Fed

Participants will receive KAI-7535 in the morning following a meal on dosing days.

Group Type EXPERIMENTAL

KAI-7535

Intervention Type DRUG

Oral tablets.

KAI-7535: Morning Dosing, Fasted

Participants will receive KAI-7535 in the morning following an overnight fast on dosing days.

Group Type EXPERIMENTAL

KAI-7535

Intervention Type DRUG

Oral tablets.

KAI-7535: Evening Dosing

Participants will receive KAI-7535 in the evening on dosing days.

Group Type EXPERIMENTAL

KAI-7535

Intervention Type DRUG

Oral tablets.

Interventions

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KAI-7535

Oral tablets.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kailera

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anaheim Clinical Trials

Anaheim, California, United States

Site Status

Countries

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United States

Other Identifiers

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K7535-1709

Identifier Type: -

Identifier Source: org_study_id

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