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

NCT06259981 | Completed Phase 2 FDA Drug

• 1 other identifier: GLY-200-03
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Glyscend, Inc.; GLY-200

Outcome Measures

Primary Outcomes (2)

• Percent change from baseline in weight

  Baseline and Week 16

• Proportion of participants who achieve ≥ 5% body weight reduction

  Baseline and Week 16

Secondary Outcomes (3)

• 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

Study Arms (2)

GLY-200

EXPERIMENTAL

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

Drug: GLY-200

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GLY-200 DRUG

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

GLY-200

Placebo DRUG

4 placebo capsules orally twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glyscend, Inc.: lead

Study Sites (5)

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Mercury Street Medical

Butte, Montana, 59701, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Fineman, PhD

  Glyscend, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 14, 2024
• Study Start: May 20, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)