Glutide for Ending Methamphetamine (NCT07204249) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Glutide for Ending Methamphetamine
162 participantsStarted 2026-01-15
Plain-language summary
GEM is a two-phase study to evaluate the use of semaglutide (Wegovy) for the treatment of methamphetamine use disorder (MeUD).
The first phase is a pilot study, which will be an open-label, single-arm pilot study of 25 participants. Participants will receive Wegovy over a 12-week treatment period, with a subsequent follow-up visit at week 20. This phase will evaluate the feasibility, acceptability, and preliminary efficacy of Wegovy for MeUD.
The second phase will be a phase IIb randomized-controlled trial to determine the efficacy of Wegovy in treating MeUD. This trial will be similar to the pilot with randomization to Wegovy or placebo and blinding of group assignment. The trial will enroll 162 participants across two sites.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study,
✓. Age 18 - 65 years inclusive,
✓. Moderate to severe Methamphetamine Use Disorder by Structured Clinical Interview for DSM Disorders (SCID),
✓. Self-reported methamphetamine use ≥15 days out of the past 30,
✓. Methamphetamine-positive urine during screening and run-in period,
✓. Interested in stopping or reducing meth use,
✓. BMI ≥ 25kg/m2,
✓. Have at least 1 centimeter of scalp hair,
Exclusion criteria
✕. Uncontrolled hypertension or systolic BP \>160 mmHg and/or diastolic BP \>90 mmHg, averaged from three measurements,
✕. Resting heart rate greater than 100 bpm at baseline, on at least two measurements,
What they're measuring
1
Ratio of eligible to enrolled participants
Timeframe: 14 months
2
Proportion of on-time injections
Timeframe: 20 months
3
Past month methamphetamine use at baseline vs. week 12
✕. Diabetes (type 1 or 2), hemoglobin A1c ≥ 6.5 at screening, or history of diabetic ketoacidosis,
✕. History or current hypoglycemia (blood glucose \<70 mg/dL),
✕. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
✕. History of heart failure or severe gastrointestinal disease (including acute or chronic pancreatitis, any gastric emptying disorder, gallbladder disease; any gastric resection),
✕. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B,
✕. Impaired renal function (estimated GFR \<60 ml/min),