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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: GLY-200

• Registration Number: NCT06259981
• Lead Sponsor: Glyscend, Inc.

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.

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-14
• Study Start: 2024-05-20
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-23
• Disposition First Posted: 2024-11-20
• Status Verified: 2025-01
• Disposition First Submitted: 2025-01-17
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks.
GLY-200	GLY-200	Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in weight	Baseline and Week 16
Proportion of participants who achieve ≥ 5% body weight reduction	Baseline and Week 16

Secondary Outcome Measures

Name	Time	Method
Change and percent change from baseline in weight	Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Change from baseline in waist circumference	Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration	Over the 16-week treatment period

Trial Locations

Locations (5)

Sensible Healthcare, LLC; 🇺🇸 Ocoee, Florida, United States

Tampa Bay Medical Research, Inc.; 🇺🇸 Clearwater, Florida, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

Tandem Clinical Research; 🇺🇸 Marrero, Louisiana, United States

Mercury Street Medical; 🇺🇸 Butte, Montana, United States