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RecruitingPhase 2Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
Evaluation Of Semaglutide Safety and Tolerability in Adults With Cocaine Use Disorder With and Without HIV
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
2
Recruiting sites
2
Enrollment
40
estimated
Study population
Alcohol / substance use, HIV
Key I/E criterion
•BMI 20-50
Primary endpoints
•Serious AEs (any)•Tolerability of semaglutide
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. At least 18 years old
2. Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5
3. Used cocaine at least 7 out of the past 14 days
4. Body Mass Index between 20 - 50 kg/m2
5. English proficiency
6. In people of childbearing potential, agree to use an acceptable method of birth control
Exclusion criteria
1. Triglycerides > 500 mg/dL
2. History of gall bladder disease
3. Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. History of diabetic retinopathy
5. Being prescribed glucose-lowering medications
6. An estimated glomerular filtration rate of less than 45 ml/min
7. Lifetime history of taking semaglutide or other GLP-1 RAs
8. Current suicidal ideation or suicide attempts within the past 24 months
9. Present diagnosis of diabetes mellitus OR screening hemoglobin A1C >/= 6.5
10. Use of weight-lowering medications
11. History of gastric bypass surgery
12. History of myocardial infarction or stroke within the past 12 months
13. Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
14. Any contraindicated medical issues identified by the study investigators
15. Risk of conditions that are under Warning and Precautions section of OZEMPIC and WEGOVY including but not limited to known history or current report of clinically relevant hypoglycemia, gastroparesis, or pancreatic disease.
16. Calcitonin value equal to or above 50 ng/L
17. If completing the MRI portion of the study: claustrophobia or physical issues preventing MRI scan
18. If completing the MRI portion of the study: presence of a metal device in the body (e.g. pacemaker. Infusion pump, aneurysm clip, metal prosthesis or plate
Endpoints (22)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsDetermine if semaglutide effects changes in body fat in individuals with cocaine use disorder, with and without HIV
Time frame:16 weeks
Total fat mass
change from baseline, event
Determine if semaglutide effects body fat distribution in people with CUD with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide effects changes muscle mass in patients with cocaine use disorder, with and without HIV
Time frame:16 weeks
Lean mass
percent change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsDetermine if semaglutide changes levels of inflammatory biomarkers in patients with HIV relative to those without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide changes levels of clinically relevant cardiovascular biomarkers in patients with HIV relative to those without HIV
Time frame:16 weeks
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Patient-reported / QoL
7 endpointsDetermine if semaglutide reduces impulsiveness in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide impacts depression in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide impacts anxiety in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide impacts anhedonia in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide impacts sleep in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide impacts sexual desire in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide impacts food cravings in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Safety / tolerability / PK
2 endpointsSafety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV
Time frame:16 weeks
Serious AEs (any)
event count, event
Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV
Time frame:16 weeks
descriptive
Other clinical outcomes
8 endpointsDetermine if semaglutide improves cocaine use frequency in people with CUD with and without HIV
Time frame:16 weeks
Alcohol consumption, change
change from baseline, improvement
Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
Time frame:16 weeks
Alcohol consumption, change
change from baseline, improvement
Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide reduces cocaine craving for people with CUD with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide reduces drug use severity for people with CUD with and without HIV
Time frame:16 weeks
AUDIT score
change from baseline, improvement
Determine if semaglutide reduces risk taking behavior in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if semaglutide reduces compulsivity in people with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, improvement
Determine if s.c. semaglutide produces changes in brain function in patients with cocaine use disorder, with and without HIV
Time frame:16 weeks
change from baseline, descriptive
componentsbrain metabolite levels mrs, resting state functional connectivity, bbb permeability asl
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.