Obesity (BMI Equal to Or >30) / Semaglutide 2.0 mg / Alcohol Use Disorder (AUD) · Phase 1 Trial

Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 1 trial comparing semaglutide 1.0 mg and 2.0 mg to placebo in patients with alcohol use disorder and obesity, with alcohol use days at 20 weeks as the primary outcome. No results are yet available in this registry record; the study has not begun recruitment.

What was studied

Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Other purpose. Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30); age from 18 Years; to 68 Years. Intervention: Semaglutide 1.0 mg; Semaglutide 2.0 mg. Compared with: Placebo — Placebo Comparator. n = 90. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1 interventional trial registration with no results posted; it describes a planned study of semaglutide in alcohol use disorder, not yet recruiting.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Alcohol use days (assessed at 20 weeks)

DesignPhase 1, Interventional, Randomized, Parallel, Quadruple masking, Other purpose

PopulationAlcohol Use Disorder (AUD), Obesity (BMI Equal to or >30); age from 18 Years; to 68 Years

Sample size90

InterventionSemaglutide 1.0 mg; Semaglutide 2.0 mg

ComparatorPlacebo — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment90

Study phasePhase 1

Primary outcome measureAlcohol use days at 20 weeks

Semaglutide dose 11.0 mg

Semaglutide dose 22.0 mg

Caveats

This is a registry record only; no results are reported and recruitment has not yet begun.
Phase 1 design is exploratory and typically underpowered to detect clinically meaningful effects.
Secondary outcomes (craving, stress hormone levels) are mentioned in the summary but not formally listed; their measures are not specified.
Blinding, randomization method, and statistical analysis plan are not described in the registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional trial with placebo control and dose comparison stated.

Directness

moderate

Directly addresses alcohol use days as primary outcome in AUD population.

Consistency

insufficient

No results reported; consistency cannot be assessed at registration stage.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or analytic plan.

Sample adequacy

limited

Estimated 90 participants total across three arms; Phase 1 study typically underpowered.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07772960). This is a study registration, not published results. Lead sponsor: Yale University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30). Interventions: OTHER: Placebo; DRUG: Semaglutide 1.0 mg; DRUG: Semaglutide 2.0 mg. Primary outcome measures: Alcohol use days , 20 weeks. Brief summary: This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Obesity (BMI Equal to Or >30)Yale UniversitySemaglutide 2.0 mgAlcohol Use Disorder (AUD)NCT07772960Semaglutide 1.0 mg