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.

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.

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