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 range

18 Years – 55 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

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

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