DelfaGLP-1 Atlas

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DREAM

Active not recruitingPhase 2

Dapiglutide for the Treatment of Obesity

Dapiglutide for the Treatment of Obesity (DREAM): a Randomised, Double-blind, Placebo-controlled, Investigator-initiated Trial

Asset

Dapiglutide

Subcutaneous · GLP-1 / GLP-2 dual

Listed sites

1

Recruiting sites

—

Enrollment

54

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

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 IDNCT05788601
Org study IDThe 'DREAM' trial
Secondary ID2022-501649-54-00EU Trial Number

Timeline

Milestones

Study first posted2023-03-29actual
Study start2023-04-27actual
Primary completion2024-04-24actual
Last update posted2024-12-05actual
Study completion2025-08-15estimated

Assets

Investigational agents

Dapiglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Age 18-75 years
•BMI ≥ 30 kg/m²
•History of at least one attempt to lose body weight

Exclusion criteria

•A self-reported change in body weight ≥ 5% within the last 90 days prior to the screening visit
•Treatment with any therapy, including endoscopic procedures and/or medication (e.g. liraglutide, bupropion/naltrexone and orlistat), intended for weight management within 90 days prior to screening
•Previous, current, or planned (during the trial period) obesity treatment with surgery or a weight loss device < 1 year prior to screening
•Glycated haemoglobin (HbA1c) ≥ 48 mmol/mol
•History of type 1 diabetes or type 2 diabetes
•Treatment with glucose-lowering agents within 90 days prior to screening
•Compromised kidney function (estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2) at screening
•Known liver disease (except for non-alcoholic fatty liver disease) and/or elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at screening
•History of acute and/or chronic pancreatitis
•History and/or family history of medullary carcinoma and/or multiple endocrine neoplasia syndrome
•Inflammatory bowel disease
•Any history of colon cancer or intestinal polyps
•Any history of intestinal stenosis
•History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least five years
•Uncontrolled thyroid disease as per discretion of the investigators
•Any of the following: myocardial infarction, stroke, hospitalisation for angina and transient ischaemic attack within the last 60 days prior to screening
•Class IV heart failure according to the New York Heart Association
•Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardise the participant's safety during the trial
•Alcohol/drug abuse as per discretion of the investigators
•Known or suspected hypersensitivity to the trial product or related products
•Previous treatment with the trial product
•Administration of an investigational drug within 90 days prior to screening
•Simultaneous participation in any other clinical intervention trial
•Mental incapacity or language barriers that preclude adequate understanding or cooperation, or unwillingness to comply with trial requirements
•Use of GLP-1RA, GLP-2RA, dipeptidyl peptidase 4 (DPP) inhibitors, human growth hormone, somatostatin, or analogues thereof, within three months prior to screening
•Known radiation enteritis or significant villous atrophy, e.g., due to active coeliac disease or inflammatory bowel disease
•Regarding fertile men and women:
–Women who are pregnant, breastfeeding, intend to become pregnant or are of childbearing potential will not be included in the study
–Sterilised or postmenopausal women (> 12 months amenorrhoea or females ≥ 60 years of age) can be included
–The following contraceptive methods are considered adequate for study enrolment of male participants: Surgically sterilised or willing to refrain from sexual intercourse from screening and until completion of the follow-up visit, or, if sexually active, condom usage and partner-practised contraception during the trial, i.e., from screening to the last visit

Endpoints (19)

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
6
MASH / liver
4
Cardiometabolic biomarkers
4
Patient-reported / QoL
2
Safety / tolerability / PK
2
Other (unclassified)
1

Weight & body composition

6 endpoints
Primary/protocol endpoint

Percentage change in body weight (kg)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body weight reduction ≥ 5%

Time frame:From week 0 (baseline) to week 12 (end of treatment)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body weight reduction ≥ 10%

Time frame:From week 0 (baseline) to week 12 (end of treatment)

≥10% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Body weight reduction ≥ 15%

Time frame:From week 0 (baseline) to week 12 (end of treatment)

≥15% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Change in BMI (kg/m2)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

BMI, change

change from baseline, improvement

Other/protocol endpoint

Change in body composition as measured by bioimpedance

Time frame:From week 0 (baseline) to week 12 (end of treatment)

change from baseline, improvement

MASH / liver

4 endpoints
Other/protocol endpoint

Change in FibroScan®-assessed liver steatosis (dB/m)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

change from baseline, improvement

Other/protocol endpoint

Change in FibroScan®-assessed liver fibrosis (kPa)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

Liver stiffness (VCTE), change

change from baseline, improvement

Other/protocol endpoint

Change in Fatty liver index score (FLI)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

change from baseline, improvement

Other/protocol endpoint

Change in fibrosis 4 score (FIB-4)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in fasting serum/plasma concentrations of inflammation markers (hs-CRP and IL-6)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

hs-CRP, change

change from baseline, improvement

componentshs-CRP, change, il6 change

LOINC 30522-7

Other/protocol endpoint

Change in systolic blood pressure (mmHg)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Change in diastolic blood pressure (mmHg)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other/protocol endpoint

Change in resting heart rate (beats per minute)

Time frame:From week 0 (baseline) to week 12 (end of treatment)

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Other/protocol endpoint

Change in the 36-Item Short Form Survey

Time frame:From week 0 (baseline) to week 12 (end of treatment)

SF-36 total

change from baseline, improvement

Other/protocol endpoint

Change in IWQOL-Lite-CT

Time frame:From week 0 (baseline) to week 12 (end of treatment)

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Number of treatment-emergent AEs

Time frame:From signed consent form (week -3) to follow-up visit (week 16)

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Number of serious AEs (SAEs)

Time frame:From signed consent form (week -3) to follow-up visit (week 16)

Serious AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in fasting serum/plasma concentrations of gut permeability biomarker (LPS-binding protein (LBP))

Time frame:From week 0 (baseline) to week 12 (end of treatment)

change from baseline, improvement

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

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.