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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259981
• Other study ID #: GLY-200-03
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Glyscend, Inc.
• Contact: Rachael Farley
• Phone: 513-579-9911
• Email: R.farley[@]medpace.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• GLY-200
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily
• Placebo
4 placebo capsules orally twice daily

Locations

Country	Name	City	State
United States	Mercury Street Medical	Butte	Montana
United States	Tampa Bay Medical Research, Inc.	Clearwater	Florida
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Glyscend, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in weight		Baseline and Week 16
Primary	Proportion of participants who achieve = 5% body weight reduction		Baseline and Week 16
Secondary	Change and percent change from baseline in weight		Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Secondary	Proportion of participants who achieve = 10% body weight reduction		Baseline and Week 16
Secondary	Change from baseline in waist circumference		Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
Secondary	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