GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT04199728

CompletedPhase 1, PHASE2Results posted

Use of a GLP-1R Agonist to Treat Opioid Use Disorder

Lead sponsor

Milton S. Hershey Medical Center

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Alcohol / substance use

Key I/E criterion

—

Primary endpoints

•Self-reported Cue-elicited Drug Craving•Ambient Drug Craving Over Time

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 IDNCT04199728

Org study ID13559

Secondary ID1UG3DA050325-01

Timeline

Milestones

Study first posted2019-12-16actual

Study start2021-10-18actual

Primary completion2023-09-13actual

Study completion2023-09-13actual

Last update posted2024-11-06actual

Results first posted2024-11-06actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 18 to 75 years

•Diagnosed with an OUD seeking treatment at Caron Treatment Centers (CaronTC) and planning on being enrolled in a residential treatment plan for a minimum of 4 weeks

•Women of childbearing potential must consent to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study

•Able and willing to provide informed consent prior to any study-related activities

•Must be able to read and communicate in English sufficiently to complete all study requirements, including Ecology Momentary Assessment (EMA)

Exclusion criteria

•Age < 18 or > 75 years

•Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures

•History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to liraglutide or another glucagon-like peptide-1 receptor (GLP1R) agonist

•Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) or thyroid nodule

•Type I diabetes or history of diabetic ketoacidosis

•Type II diabetes mellitus

•Hypoglycemia on intake visit (blood glucose < 70 mg/dL)

•End-stage renal failure on dialysis or glomerular filtration rate (GFR) <30 mL/min per 1.73 square meters or previous renal transplant

•Severe hepatic impairment (AST or ALT levels > 3 times upper limit of normal range) or previous liver transplant

•Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal disease

•Current or past diagnosis of gallbladder disease or gallstones

•Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke)

•Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia) that would, in the opinion of the Principle Investigator or study physician, interfere with participating in the study, such as if the patient needs a higher or different level of care and is going to be transferred out of Caron.

•Suicidal ideation within the past 1 month, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and/or judgement.

•Treatment with any investigational drug in the one-month preceding the study

•Previous randomization for participation in this trial

•Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by study physician

Endpoints (30)

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

4 endpoints

Secondary/registry result

Absolute Change in Body Weight

Time frame:From Day 1 to Day 19

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Investigational Group	0.27	—
Control Group	1.05	—

Secondary/registry result

Percent Change in Body Weight

Time frame:From Day 1 to Day 19

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), % change	95% CI
Investigational Group	0.33	—
Control Group	1.38	—

Secondary/protocol endpoint

Absolute Change in Body Weight

Time frame:From Day 1 to Day 19

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight

Time frame:From Day 1 to Day 19

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/registry result

Change in Fasting Blood Samples for Fructosamine

Time frame:From Day 2 to Day 19

change from baseline, improvement

Posted result

Group	Value (mean), umol/L	95% CI
Investigational Group	-14.00	—
Control Group	2.71	—

Secondary/registry result

Change in Fasting Blood Samples for HA1c

Time frame:From Day 2 to Day 19

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), % of total hemoglobin in the blood	95% CI
Investigational Group	-0.10	—
Control Group	0	—

Secondary/protocol endpoint/low confidence

Change in Fasting Blood Samples for Fructosamine

Time frame:From Day 2 to Day 19

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Blood Samples for HA1c

Time frame:From Day 2 to Day 19

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Change in Blood Pressure

Time frame:Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

change from baseline, improvement

Posted result

Group	Value (mean), mmHg	95% CI
Investigational GroupSystolic Pressure, from Day 2	4.00	—
Systolic Pressure, from Day 8	9.00	—
Systolic Pressure, from Day 14	3.75	—
Diastolic Pressure, from Day 2	3.00	—
Diastolic Pressure, from Day 8	2.25	—
Diastolic Pressure, from Day 14	2.75	—
Control GroupSystolic Pressure, from Day 2	-0.59	—
Systolic Pressure, from Day 8	2.75	—
Systolic Pressure, from Day 14	2.13	—
Diastolic Pressure, from Day 2	2.56	—
Diastolic Pressure, from Day 8	3.34	—
Diastolic Pressure, from Day 14	4.19	—

Secondary/registry result

Change in Heart Rate

Time frame:Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute	95% CI
Investigational GroupDay 02 change from baseline	10.75	—
Day 08 change from baseline	20.00	—
Day 14 change from baseline	9.75	—
Control GroupDay 02 change from baseline	-5.78	—
Day 08 change from baseline	-2.63	—
Day 14 change from baseline	-3.09	—

Secondary/protocol endpoint

Change in Blood Pressure

Time frame:Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

change from baseline, improvement

Secondary/protocol endpoint

Change in Heart Rate

Time frame:Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

Heart rate, change

change from baseline, improvement

Other/protocol endpoint

Rebound Change in Blood Pressure

Time frame:From end of the target drug dose (Day 19) to rebound follow up (Day 21).

change from baseline, improvement

Other/protocol endpoint

Rebound Change in Heart Rate

Time frame:From end of the target drug dose (Day 19) to rebound follow up (Day 21).

Heart rate, change

change from baseline, improvement

Other_pre_specified/registry result

Rebound Change in Blood Pressure

Time frame:From end of the target drug dose (Day 19) to rebound follow up (Day 21).

change from baseline, improvement

Posted result

Group	Value (mean), mmHg	95% CI
Investigational GroupChange in systolic pressure	11.00	—
Change in diastolic pressure	10.25	—
Control GroupChange in systolic pressure	-0.56	—
Change in diastolic pressure	-1.59	—

Other_pre_specified/registry result

Rebound Change in Heart Rate

Time frame:From end of the target drug dose (Day 19) to rebound follow up (Day 21).

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute	95% CI
Investigational Group	8.50	—
Control Group	-6.31	—

Patient-reported / QoL

3 endpoints

Primary/registry result

Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)

Time frame:Baseline (Day 1), End of the target drug dose (Day 19)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
Investigational Group	-5.00	—
Control Group	-13.34	—

Primary/registry result

Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)

Time frame:Baseline (Day 1), Treatment Days (Days 2-19)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
Investigational Group	-0.55	—
Control Group	-1.41	—

Other_pre_specified/registry result

Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)

Time frame:Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
Investigational Group	-0.11	—
Control Group	-0.15	—

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Change in Respiratory Rate

Time frame:Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

change from baseline, descriptive

Posted result

Group	Value (mean), breaths per minute	95% CI
Investigational GroupDay 02 change from baseline	-1.00	—
Day 08 change from baseline	0.67	—
Day 14 change from baseline	1.33	—
Control GroupDay 02 change from baseline	0.08	—
Day 08 change from baseline	-1.08	—
Day 14 change from baseline	-0.13	—

Secondary/registry result

Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame:Days 1-21 and at 30 days post-intervention (Day 49).

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

Group	Value (count_of_participants), Participants	95% CI
Investigational GroupParticipants with drug-related AEs	5	—
Participants with drug-related SAEs	1	—
Control GroupParticipants with drug-related AEs	3	—
Participants with drug-related SAEs	0	—

Secondary/protocol endpoint

Change in Respiratory Rate

Time frame:Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

change from baseline, descriptive

Secondary/protocol endpoint

Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame:Days 1-21 and at 30 days post-intervention (Day 49).

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Other/protocol endpoint

Rebound Change in Respiratory Rate

Time frame:From end of the target drug dose (Day 19) to rebound follow up (Day 21).

change from baseline, descriptive

Other_pre_specified/registry result/low confidence

Rebound Change in Respiratory Rate

Time frame:From end of the target drug dose (Day 19) to rebound follow up (Day 21).

change from baseline, descriptive

Posted result

Group	Value (mean), breaths per minute	95% CI
Investigational Group	-6.33	—
Control Group	-0.67	—

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)

Time frame:Baseline (Day 1), End of the target drug dose (Day 19)

change from baseline, improvement

Primary/protocol endpoint

Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)

Time frame:Baseline (Day 1), Treatment Days (Days 2-19)

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)

Time frame:Baseline (Day 1), end of the target drug dose (Day 19)

change from baseline, descriptive

Other/protocol endpoint/low confidence

Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)

Time frame:Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)

AUDIT score

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)

Time frame:Baseline (Day 1), end of the target drug dose (Day 19)

change from baseline, descriptive

Posted result

Group	Value (mean), Optical density (OD)	95% CI
Investigational Group	-3.10	—
Control Group	-0.58	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Ecological momentary assessment and cue-elicited drug craving as primary endpoints: study protocol for a randomized, double-blind, placebo-controlled clinical trial testing the efficacy of a GLP-1 receptor agonist in opioid use disorder.
Addiction science & clinical practice2024 Jul 27PMID39061093doi:10.1186/s13722-024-00481-7via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.