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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: GLY-200; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rachael Farley; Phone Number: 11961 513-579-9911; Email: R.farley@medpace.com

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research, Inc.
      • Principal Investigator: Sureka Bollepalli
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare, LLC
      • Principal Investigator: Kelly Taylor
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
      • Principal Investigator: Gary Reiss
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical
      • Principal Investigator: John Pullman
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
      • Principal Investigator: Parke Hedges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLY-200; Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks.	Drug: GLY-200; 2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily
Placebo Comparator: Placebo; Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks.	Drug: Placebo; 4 placebo capsules orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Change and percent change from baseline in weight	Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Proportion of participants who achieve ≥ 10% body weight reduction	Baseline 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

Collaborators and Investigators

• Sponsor: Glyscend, Inc.
• Investigators: Study Chair: Mark Fineman, PhD, Glyscend, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; GLY-200; Glyscend, Inc.
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: GLY-200-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No