Obesity
Conditions
Keywords
Obesity, Glyscend, Inc., GLY-200
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.
Interventions
DRUGGLY-200
2.0 g GLY-200 (4 x 0.5 g capsules) orally twice daily
DRUGPlacebo
4 placebo capsules orally twice daily
Sponsors
Glyscend, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
| 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 |
Countries
United States
Outcome results
None listed