LivingGLP1
Study S000504

Semaglutide Therapy for Alcohol Reduction (STAR): A Proof-of-Concept Phase II Clinical Trial

ClinicalTrials.gov record

Registration

Registration
NCT06015893
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
TRIPLE
Status
ACTIVE_NOT_RECRUITING
Enrollment
63
Start
2023-10-17
Primary completion
2027-03-31
Lead sponsor
National Institute on Drug Abuse (NIDA)
Conditions
Addiction; Alcohol Use Disorder
Interventions
BEHAVIORAL:Take Control; DRUG:Semaglutide
Results posted
FALSE
Individual participant data sharing
UNDECIDED
Secondary identifiers
OTHER:001603-DA

Registered primary outcomes

  • Determine whether semaglutide, compared to placebo, reduces alcohol drinking. [Difference in number of standard alcohol-containing drinks consumed / week (Drinks Per Week, DPW) from baseline to end of the study.]

Linked records (8)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0010965The glucagon-like peptide-1 (GLP-1) analogue semaglutide reduces alcohol drinking and modulates central GABA neurotransmission.
Chuong V, JCI insight
2023PreclinicalPMID 37192005DOIregistry reference BACKGROUND:37192005
R0022288The role of glucagon-like peptide 1 (GLP-1) in addictive disorders.
Klausen MK, British journal of pharmacology
2022PreclinicalPMID 34532853DOIregistry reference BACKGROUND:34532853
R0024390The glucagon-like peptide-1 system is modulated by acute and chronic alcohol exposure: Findings from human laboratory experiments and a post-mortem brain study.
Farokhnia M, Addiction biology
2022Randomized trialPMID 36001436DOIregistry reference BACKGROUND:36001436
R0008972Long-Acting Glucagon-Like Peptide-1 Receptor Agonists Suppress Voluntary Alcohol Intake in Male Wistar Rats.
Marty VN, Frontiers in neuroscience
2020PreclinicalPMID 33424537DOIregistry reference BACKGROUND:33424537
R0018024Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species.
Jensen L, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
2017PreclinicalPMID 28323117DOIregistry reference BACKGROUND:28323117
R0018398Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.
Lau J, Journal of medicinal chemistry
2015Other trialPMID 26308095DOIregistry reference BACKGROUND:26308095
R0026443The glucagon-like peptide-1 receptor as a potential treatment target in alcohol use disorder: evidence from human genetic association studies and a mouse model of alcohol dependence.
Suchankova P, Translational psychiatry
2015Nonrandomized studyPMID 26080318DOIregistry reference BACKGROUND:26080318
R0025909The structure and function of the glucagon-like peptide-1 receptor and its ligands.
Donnelly D, British journal of pharmacology
2012Narrative reviewPMID 21950636DOIregistry reference BACKGROUND:21950636