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

NCT02377362 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-03-21

Study results available
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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

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

Sponsors & Collaborators

  • GLWL Research Inc.

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-11-09
Completion
2016-11-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02377362 on ClinicalTrials.gov