NCT06040372

A First in Human Study to Assess the Safety, Tolerability of LB54640 in in Healthy Overweight and Obese Subjects

Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Compound LB54640 in Healthy Overweight and Obese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the Safety and Tolerability of LB54640 in Healthy overweight and obese subjects

Detailed description

The study was conducted in 2 parts: Part 1 (Single Ascending Dose) This study part included 6 sequential dose cohorts (S1-S6), enrolling 8 healthy subjects per cohort. Cohort S3 was evaluate the effect of food. Part 2 (Multiple Ascending Dose) This part included 7 sequential dose cohorts (M1-M7), enrolling 8 subjects per cohort. Cohorts was evaluate safety, Pharmacokinetics and Pharmacodynamics parameters in healthy overweight and obese subjects. They were dosed once daily for 28 days with LB54640 or placebo.

Conditions

• Obese
• Overweight
• Healthy

Interventions

Type	Name	Description
DRUG	LB64640	The investigational product (IP) LB54640 is provided 5 mg, 25 mg and 200 mg strengths.
DRUG	Placebo	Placebo is provided as a matching placebo

Timeline

• Start date: 2020-03-16
• Primary completion: 2022-03-30
• Completion: 2022-07-30
• First posted: 2023-09-15
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study