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

United States18 participantsStarted 2025-12-15

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Pre-dose and up to 60 hours post-dose

Maximum Observed Concentration (Cmax) of KAI-7535

Timeframe: 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

Timeframe: Pre-dose and up to 60 hours post-dose

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

Timeframe: Pre-dose and up to 60 hours post-dose

Trial details

NCT IDNCT07294898

SponsorKailera

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-26

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