DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06639464

SHORE

RecruitingPhase 2

Semaglutide for Helping Opioid Recovery

Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

46

estimated

Study population

Alcohol / substance use

Key I/E criteria

•BMI ≤25•eGFR ≤60

Primary endpoints

•AUDIT score•Relapse to Illicit Opioid Use

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

NCT IDNCT06639464
Org study ID2024P002669

Timeline

Milestones

Study first posted2024-10-15actual
Study start2025-06-02actual
Last update posted2025-09-26actual
Primary completion2026-08-31estimated
Study completion2026-08-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

•English speaking adults aged 18 and above
•DSM-5 diagnosis of opioid use disorder, severe
•Initiated sublingual buprenorphine (SL-BUP) treatment within 60 days of enrollment
•Attained stable dosing of SL-BUP of 16mg or greater for 30 days prior to enrollment
•Anticipating continuation of SL-BUP for the duration of the trial
•Agreeable with bringing SL-BUP prescription to visits to allow study team to conduct a dose count
•Willing to grant study team permission to communicate about SL-BUP treatment with community prescriber via completion of 42 CFR release

Individuals with any of the following will be excluded:

•DSM-5 diagnosis of any current substance use disorder excluding opioid, cannabis or tobacco
•Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
•Any current or lifetime diagnosis of eating disorders
•BMI<25mg/kg2
•Current or lifetime diagnosis of Type 1 or Type 2 diabetes
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
•Use of any GLP-1 agonist medications in the prior 3 months
•Anticipating receipt of any GLP-1 agonist medications during the trial
•History of angina pectoris, coronary heart disease, congestive heart failure, inflammatory bowel disease, chronic obstructive pulmonary disease, bariatric surgery, idiopathic pancreatitis, diabetic gastroparesis
•Liver function test greater than 3 times upper normal limit
•Renal impairment as indicated by eGFR of <60
•History of hypersensitivity or allergy to semaglutide
•Pregnant or breastfeeding
•Anticipated to participate in a concurrent drug trial
•Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

Endpoints (21)

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

Patient-reported / QoL
6
Other clinical outcomes
6
Safety / tolerability / PK
3
Weight & body composition
2
Glycemic / diabetes
2
Cardiometabolic biomarkers
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Height

Time frame:Weekly from baseline to end of study at 14 weeks

descriptive

Secondary/protocol endpoint

Weight

Time frame:Weekly from baseline to end of study at 14 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Hemoglobin A1c

Time frame:At baseline and 13 weeks after baseline visit

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Blood sugar

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Heart Rate

Time frame:Weekly from baseline to end of study at 14 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, improvement

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint/low confidence

Monetary Choice Questionnaire (MCQ)

Time frame:Baseline, 6 weeks, and 13 weeks after baseline visit

descriptive

Secondary/protocol endpoint

Patient Health Questionnaire (PHQ8)

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Generalized Anxiety Disorder (GAD7)

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, improvement

Secondary/protocol endpoint

WHO Quality of Life (WHOQOL-BREF)

Time frame:Baseline and 13 weeks after baseline visit

change from baseline, improvement

Secondary/protocol endpoint

Stanford Efficacy of treatment Scale (SETS)

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Temporal Experience of Pleasure Scale (TEPS)

Time frame:At baseline and 13 weeks after baseline visit

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Patient Rated Inventory of Side Effects (PRISE)

Time frame:Weekly from 2 weeks after baseline to end of study at 14 weeks

descriptive

Secondary/protocol endpoint

Columbia suicide severity rating scale (C-SSRS)

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, event

Secondary/protocol endpoint

Assessment of blind

Time frame:6 weeks and 13 weeks after baseline visit.

descriptive

Other clinical outcomes

6 endpoints
Primary/protocol endpoint/low confidence

Cue-induced Cravings for Opioids

Time frame:Baseline, 6 weeks, and 13 weeks after baseline visit

AUDIT score

change from baseline, improvement

Primary/protocol endpoint

Relapse to Illicit Opioid Use

Time frame:Weekly from baseline to end of study at 14 weeks

threshold achievement, event

Secondary/protocol endpoint/low confidence

Visual Probe Task

Time frame:Baseline, 6 weeks, and 13 weeks after baseline visit

descriptive

Secondary/protocol endpoint

Iowa Gambling Task (IGT)

Time frame:Baseline, 6 weeks, and 13 weeks after baseline visit

descriptive

Secondary/protocol endpoint

Clinical Opiate Withdrawal Scale (COWS)

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Opioid Craving Scale

Time frame:Weekly from baseline to end of study at 14 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.