NCT05788601: DREAM

Dapiglutide for the Treatment of Obesity

Active, enrolled Phase 2 Last updated 5 December 2024

What this trial tests

Phase 2 trial testing Dapiglutide in Obesity in 54 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 April 2023

Primary endpoint
24 April 2024

15 August 2025

Quick facts

Lead sponsor	University Hospital, Gentofte, Copenhagen
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	54
Start date	27 April 2023
Primary completion	24 April 2024
Estimated completion	15 August 2025
Sites	1 location across Denmark

Drugs / interventions tested

• Dapiglutide — full drug profile →
• Placebo

Conditions studied

• Obesity — all drugs for Obesity →
• Inflammation — all drugs for Inflammation →

Sponsor

University Hospital, Gentofte, Copenhagen

Who can join

Adults 18 to 75, any sex, with Obesity or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, parallel-group, single-centre clinical trial investigating the body weight loss potential of dapiglutide, a dual GLP-1R/GLP-2R agonist, administered subcutaneously once weekly. The study will investigate the efficacy of once-weekly subcutaneously administered of 4 mg and 6 mg dapiglutide versus placebo in 54 obese individuals (BMI \>30 kg/m2) during a 12-week treatment period.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. What is the pipeline for future medications for obesity?
   Melson E, Ashraf U, Papamargaritis D, Davies MJ. · · 2025 · cited 147× · PMID 38302593 · DOI 10.1038/s41366-024-01473-y
2. Recent achievements and future directions of anti-obesity medications.
   Grandl G, Novikoff A, Liu X, Müller TD. · · 2024 · cited 10× · PMID 39582489 · DOI 10.1016/j.lanepe.2024.101100
3. Molecular Mechanisms behind Obesity and Their Potential Exploitation in Current and Future Therapy.
   Nicze M, Dec A, Borówka M, Krzyżak D, et al · · 2024 · cited 9× · PMID 39125772 · DOI 10.3390/ijms25158202
4. Approved and Emerging Hormone-Based Anti-Obesity Medications: A Review Article.
   Sidrak WR, Kalra S, Kalhan A. · · 2024 · cited 8× · PMID 39676791 · DOI 10.4103/ijem.ijem_442_23
5. Evolving Approaches for Pharmacological Therapy of Obesity.
   Chao AM, Taylor S, Moore M, Amaro A, et al · · 2025 · cited 6× · PMID 39348522 · DOI 10.1146/annurev-pharmtox-031124-101146
6. Paradigm shift in obesity treatment: an extensive review of current pipeline agents.
   Çetin E, Pedersen B, Burak MF. · · 2025 · cited 2× · PMID 40104296 · DOI 10.55730/1300-0144.5938
7. Dapiglutide, a dual GLP-1 and GLP-2 receptor agonist, for obesity: a randomised, double-blind, placebo-controlled parallel-group, proof-of-concept trial.
   Nielsen CK, Pálsson TG, Forman JL, Lukacova M, et al · · 2026 · cited 1× · PMID 41768273 · DOI 10.1016/j.eclinm.2026.103801
8. Glucose-Dependent Effects of Exogenous Glucagon-Like Peptide-2 on Circulating Glucagon Levels in Healthy Men.
   Sørum NE, Magnussen T, Hansen NL, Nielsen CK, et al · · 2026 · PMID 41541287 · DOI 10.1210/jendso/bvaf215