← Human Trials & Peer-Reviewed Studies

GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV

Plain-language guide to NCT07221214: phase 2 randomized trial of Semaglutide, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07221214
Phase
phase 2
Status
recruiting participants
Start
2026-04-17
Completion (planned or actual)
2029-10-31
Participants
200 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
HIV; Alcohol; Smoking Cigarette; Cardiovascular Disease Prevention
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Semaglutide.

The main questions it aims to answer are: 1.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Drug intervention.

The registry classes the interventions as drug.

Who Took Part

200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 89 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Prior diagnosis of HIV-1. Most recent absolute CD4 count ≥ 300 cells/mm3 and drawn within 12 months of study enrollment. BMI ≥ 23 (calculated at screening). AUDIT-C ≥ 3 (male)/ ≥ 2 (female). Has an established stable address at which they can receive mail and can be reached for the next 6 months.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: known allergy to semaglutide; currently taking glp-1 ra (in the past 3 months); history of pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-04-17 with completion listed for 2029-10-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Average drinks/week past 30 days at 3 months (time frame: 3 Months).

It also tracked 2 secondary outcomes, for example Average cigarettes per day (cpd) past 30 days at 3 months and Systemic inflammation (IL-6) at 3 months.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 200 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.