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

Glyscend

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity

Treatments: Drug: GLY-200; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06259981

GLY-200-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

GLY-200

Experimental group

Description:

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

Treatment:

Drug: GLY-200

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo