A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity

NCT ID: NCT06259981

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-10-23

Brief Summary

This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.

Detailed Description

This study is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. Approximately 70 participants will be randomized in a 1:1 ratio to GLY-200 (2.0 g, twice daily) or placebo (twice daily). There will be a ≤ 28-day screening period. Dosing will occur for 16 weeks. Clinic visits will occur at Screening, Week 0 (Day 1), and Weeks 1, 2, 4, 6, 8, 12, 16, and 17 [End of Study (EOS)] or Early Termination (ET). Phone visits will occur at Week 3, 10, and 14.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GLY-200

Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks.

Group Type: EXPERIMENTAL

GLY-200

Intervention Type: DRUG

2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily

Placebo

Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4 placebo capsules orally twice daily

Interventions

GLY-200

2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily

Intervention Type: DRUG

Placebo

4 placebo capsules orally twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, ≥ 18 and ≤ 70 years old at the time of screening
• BMI ≥ 32 and ≤ 40 kg/m² at screening

Exclusion Criteria

• Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol)
• Participants who have had an increase or decrease in body weight more than 5% within the last 3 months
• Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months
• Use of any drug treatment that affects gastric pH
• Use of any drug treatment that affects gastrointestinal motility
• Diagnosis or treatment of any symptomatic or structural abnormality of the GI tract or active disease within 12 months
• Clinically significant symptoms (as determined by the Investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glyscend, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Fineman, PhD

Role: STUDY_CHAIR

Glyscend, Inc.

Locations

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Sensible Healthcare, LLC

Ocoee, Florida, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Mercury Street Medical

Butte, Montana, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GLY-200-03

Identifier Type: -

Identifier Source: org_study_id