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Completed

NCT Number: NCT07294898

A Study to Investigate the Effect of a Low-fat Meal and Evening Dosing on KAI-7535 in 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KAI-7535

Drug

Oral tablets.

Primary outcomes

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

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

  2. Maximum Observed Concentration (Cmax) of KAI-7535

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

  3. 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

  4. 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

Secondary outcomes

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

    Time frame: Day 1 up to Day 12

Sponsors and collaborators

Lead sponsor

Kailera

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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