Clinical trial NCT06259981: A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Glyscend, Inc.
GLY-200
Lead sponsor: Glyscend, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change from baseline in weight
timeFrame: Baseline and Week 16
measure: Proportion of participants who achieve ≥ 5% body weight reduction
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Change and percent change from baseline in weight
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
measure: Change from baseline in waist circumference
timeFrame: Baseline, Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Week 16
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration
timeFrame: Over the 16-week treatment period
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Glyscend, Inc.
name: Mark Fineman, PhD
role: STUDY_CHAIR
References: