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Glutide for Ending Methamphetamine

NCT07204249 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-10-21

No results posted yet for this study

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.

Conditions

  • Methamphetamine-dependence

Interventions

DRUG

Semaglutide

Semaglutide

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • San Francisco Department of Public Health

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2030-02-15
Completion
2030-02-15
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204249 on ClinicalTrials.gov