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Glutide for Ending Methamphetamine
Plain-language guide to NCT07204249: phase 2 randomized trial of Semaglutide, 162 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07204249
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2026-02-26
- Completion (planned or actual)
- 2030-02-15
- Participants
- 162 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Methamphetamine-dependence
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Semaglutide.
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.
It had two arms (groups): Semaglutide (Wegovy) (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 162 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 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,.
The full record lists 10 inclusion and 25 exclusion criteria; among the exclusions: uncontrolled hypertension or systolic bp \>160 mmhg and/or diastolic bp \>90 mmhg, averaged from three measurements,; diabetes (type 1 or 2), hemoglobin a1c ≥ 6.5 at screening, or history of diabetic ketoacidosis,; 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.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
The Semaglutide group and the comparison group ran side by side rather than switching.
As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2026-02-26 with completion listed for 2030-02-15.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Ratio of eligible to enrolled participants (time frame: 14 months). Proportion of on-time injections (time frame: 20 months). Past month methamphetamine use at baseline vs. week 12 (time frame: 12 weeks).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Semaglutide in 162 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.