Dapiglutide for the treatment of obesity (DREAM): a randomised, double-blind, placebo-controlled, investigator-initiated trial

2022-501649-54-01 Protocol The ‘DREAM’ trial Therapeutic exploratory (Phase II) Ended

End 24 Apr 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol The ‘DREAM’ trial

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 54
Countries 1
Sites 1

Obesity

The primary aim is to evaluate the effects of 4 mg and 6 mg dapiglutide on change in body weight (%).

Key facts

Sponsor
Gentofte Hospital
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
completed 24 Apr 2024
Decision date (initial)
2023-02-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Zealand Pharma A/S

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary aim is to evaluate the effects of 4 mg and 6 mg dapiglutide on change in body weight (%).

Conditions and MedDRA coding

Obesity

Regulatory references

EU CT numberTitleSponsor
2022-501649-54-00 Dapiglutide for the treatment of obesity (DREAM): a randomised, double-blind, placebo-controlled, investigator-initiated trial Gentofte Hospital

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Age 18–75 years
  2. BMI ≥ 30 kg/m²
  3. History of at least one attempt to lose body weight

Exclusion criteria 5

  1. A self-reported change in body weight ≥ 5% within the last 90 days prior to the screening visit
  2. 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
  3. Previous, current, or planned (during the trial period) obesity treatment with surgery or a weight loss device < 1 year prior to screening
  4. Glycated haemoglobin (HbA1c) ≥ 48 mmol/mol
  5. History of type 1 diabetes or type 2 diabetes

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change in body weight

Secondary endpoints 4

  1. Body weight reduction ≥ 5%
  2. Body weight reduction ≥ 5%
  3. Change in fasting serum/plasma concentrations of gut permeability biomarkers • LPS
  4. Change in fasting serum/plasma concentrations of inflammation markers. High-sensitivity CRP. Interleukin (IL)-6

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dapiglutide

PRD9437208 · Product

Active substance
Dapiglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
6 mg milligram(s)
Max total dose
54 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
ZEALAND PHARMA
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo for dapiglutide

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

22 Total trials 10 Recruiting 9 Ended
Commercial
Sponsor organisation
Gentofte Hospital
Address
Kildegårdsvej 28
City
Hellerup
Postcode
2900
Country
Denmark

Scientific contact point

Organisation
Gentofte Hospital
Contact name
Center for Clinical Metabolic Research

Public contact point

Organisation
Gentofte Hospital
Contact name
Center for Clinical Metabolic Research

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 54 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ended
Gentofte Hospital
Center for Clinical Metabolic Research, Kildegårdsvej 28, 2900, Hellerup

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Summary of Results
SUM-108724
 2025-11-28T14:36:02 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Layperson Summary of results for CTIS Final Nov2025 2025-11-28T14:36:45 Submitted Laypersons Summary of Results

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Layperson Summary of results for CTIS Final Nov2025 1
Summary of results (for publication) Summary of Results for CTIS Final Nov2025 for publication 1

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-11-17 Denmark Acceptable
2023-01-31
 2023-02-07
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-04-03 Denmark Acceptable
2023-01-31
 2023-04-03
3 SUBSTANTIAL MODIFICATION SM-1 2023-05-31 Denmark Acceptable
2023-06-19
 2023-06-20
4 SUBSTANTIAL MODIFICATION SM-2 2023-07-03 Denmark Acceptable
2023-07-14
 2023-07-17
5 NON SUBSTANTIAL MODIFICATION NSM-3 2023-10-09 Denmark Acceptable
2023-07-14
 2023-10-09
6 SUBSTANTIAL MODIFICATION SM-3 2023-12-08 Denmark Acceptable
2023-12-15
 2023-12-17

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