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

Kailera

Status and phase: Completed; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: KAI-7535

Study type: Interventional

Funder types: Industry

Identifiers

NCT07294898

K7535-1709

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

KAI-7535: Morning Dosing, Fed

Experimental group

Description:

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

Treatment:

Drug: KAI-7535

KAI-7535: Morning Dosing, Fasted

Experimental group

Description:

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

Treatment:

Drug: KAI-7535

KAI-7535: Evening Dosing

Experimental group

Description:

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

Treatment:

Drug: KAI-7535