NCT02377362

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01

A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, and Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GLWL-01

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: GLWL Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	GLWL-01, Part A	Capsules administered orally, in 2 out of 3 periods
DRUG	Placebo, Part A	Capsules administered orally in 1 out of 3 periods
DRUG	GLWL-01, Part B	Capsules administered orally either once or twice daily for 27 days, with a single dose on Day 28
DRUG	Placebo, Part B	Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
DRUG	GLWL-01, Part C	Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
DRUG	Placebo, Part C	Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-11-09
• Completion: 2016-11-09
• First posted: 2015-03-03
• Last updated: 2019-03-21
• Results posted: 2019-03-21

Locations

4 sites across 1 country: United States