ObesityPhase 2DREAMNCT05788601
Dapiglutide for the Treatment of Obesity
A Phase 2 study testing Dapiglutide in people with Obesity and Inflammation, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation
- What is being tested?
- Dapiglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Apr 2023to 15 Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- BMI ≥ 30 kg/m²
- History of at least one attempt to lose body weight
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
Hellerup, 2900
About this study
Official title: Dapiglutide for the Treatment of Obesity (DREAM): a Randomised, Double-blind, Placebo-controlled, Investigator-initiated Trial
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.
Read the detailed description
In total, 54 obese participants with a body mass index (BMI) of ≥ 30 kg/m² are randomised to either treatment with the investigational medicinal product (IMP), being either dapiglutide 4 mg, dapiglutide 6 mg, or placebo for 12 weeks. To ensure blinding, the placebo arm is split between 4 mg and 6 mg placebo, making the randomisation sequence 2:2:1:1. The trial encompasses a 3-week screening period containing a screening visit (V1) to assess eligibility, followed by a randomisation visit (V2) and subsequently a 12-week treatment period concluded with a 4-week follow-up period. The IMP is subcutaneously administered in the abdomen once weekly from week 0 (V2) until week 12 (V14). The IMP is initiated at 2 mg once-weekly and up-titrated every third week with 2 mg until the respective trial doses are reached in each arm. Hereafter, the participants are kept at the dose level for the remainder of the trial (from week 3 and week 6 for the 4 mg and 6 mg doses, respectively). To reduce dropout in cases of low tolerability of the IMP, the investigator can postpone up-titration or down-titrate if judged necessary for participant retention or safety. The trial schedule will consist of five on-site visits, including screening, randomisation and a safety follow-up visit (four weeks after end of treatment (EOT)), in addition to a minimum of 10 telephone consultations. Therefore, the maximum trial duration is 16 weeks. For exploratory purposes, participants are invited to participate in a gastroduodenoscopy sub-study obtaining gastric and duodenal biopsies before and after treatment with IMP. A maximum of 7 participants from each treatment arm (total n=21) participate in this sub-study.
- Conditions
- Obesity, Inflammation
- Being tested
- Dapiglutide, Placebo
- Keywords
- Gut barrier function
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapiglutideDrug
Also called ZP7570
GLP-1/GLP-2 receptor agonism
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo (4 mg and 6 mg) | Placebo comparator | Abdominal s.c. self-administration of placebo content once weekly for 12 weeks. To ensure double-blinding, the placebo arm is divided into a 4-mg and 6-mg arm. But both placebo arms are pooled during data analysis. Receives: Drug: Placebo |
| 4 mg dapiglutide | Active comparator | Abdominal s.c. self-administration of 4 mg dapiglutide once weekly initiated at 2 mg and up-titrated after three weeks until the remaining nine weeks of treatment (12 weeks in total) Receives: Drug: Dapiglutide |
| 6 mg dapiglutide | Active comparator | Abdominal s.c. self-administration of 6 mg dapiglutide once weekly initiated at 2 mg and up-titrated after three weeks to 4 mg and again to 6 mg after six weeks until the remaining six weeks of treatment (12 weeks in total) Receives: Drug: Dapiglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight (kg)
%-point
Measured: From week 0 (baseline) to week 12 (end of treatment)
Secondary outcomes (4)
Body weight reduction ≥ 5%
count (yes/no)
Measured: From week 0 (baseline) to week 12 (end of treatment)
Body weight reduction ≥ 10%
count (yes/no)
Measured: From week 0 (baseline) to week 12 (end of treatment)
Change in fasting serum/plasma concentrations of gut permeability biomarker (LPS-binding protein (LBP))
%-point
Measured: From week 0 (baseline) to week 12 (end of treatment)
Change in fasting serum/plasma concentrations of inflammation markers (hs-CRP and IL-6)
%-point
Measured: From week 0 (baseline) to week 12 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start27 Apr 2023
- Primary completion24 Apr 2024
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arms: 12 weeks of 4 mg and 6 mg dapiglutide and placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand Pharma
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Principal investigator, Center for Clinical Metabolic Research at Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788601
- Sponsor's protocol ID
- The 'DREAM' trial
- Other IDs
- 2022-501649-54-00
- Acronym
- DREAM
- Status last verified
- Dec 2024
- First submitted
- 7 Feb 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this moment we do not plan to share individual participant data
Publications
Nielsen CK, Palsson TG, Forman JL, Lukacova M, Jensen BAH, Mathiesen DS, Englund A, Gether IM, Johansen NJ, Pedersen MG, Hartmann B, Holst JJ, Knop FK, Lund AB. Dapiglutide, a dual GLP-1 and GLP-2 receptor agonist, for obesity: a randomised, double-blind, placebo-controlled parallel-group, proof-of-concept trial. EClinicalMedicine. 2026 Feb 21;93:103801. doi: 10.1016/j.eclinm.2026.103801. eCollection 2026 Mar.
PubMed 41768273
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapiglutide for the Treatment of Obesity (DREAM): a Randomised, Double-blind, Placebo-controlled, Investigator-initiated Trial
- ClinicalTrials.gov ID
- NCT05788601
- Acronym / sponsor ID
- DREAM / The 'DREAM' trial
- Conditions
- Obesity, Inflammation
- Keywords
- Gut barrier function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Zealand Pharma
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In total, 54 obese participants with a body mass index (BMI) of ≥ 30 kg/m² are randomised to either treatment with the investigational medicinal product (IMP), being either dapiglutide 4 mg, dapiglutide 6 mg, or placebo for 12 weeks. To ensure blinding, the placebo arm is split between 4 mg and 6 mg placebo, making the randomisation sequence 2:2:1:1. The trial encompasses a 3-week screening period containing a screening visit (V1) to assess eligibility, followed by a randomisation visit (V2) and subsequently a 12-week treatment period concluded with a 4-week follow-up period. The IMP is subcutaneously administered in the abdomen once weekly from week 0 (V2) until week 12 (V14). The IMP is initiated at 2 mg once-weekly and up-titrated every third week with 2 mg until the respective trial doses are reached in each arm. Hereafter, the participants are kept at the dose level for the remainder of the trial (from week 3 and week 6 for the 4 mg and 6 mg doses, respectively). To reduce dropout in cases of low tolerability of the IMP, the investigator can postpone up-titration or down-titrate if judged necessary for participant retention or safety. The trial schedule will consist of five on-site visits, including screening, randomisation and a safety follow-up visit (four weeks after end of treatment (EOT)), in addition to a minimum of 10 telephone consultations. Therefore, the maximum trial duration is 16 weeks. For exploratory purposes, participants are invited to participate in a gastroduodenoscopy sub-study obtaining gastric and duodenal biopsies before and after treatment with IMP. A maximum of 7 participants from each treatment arm (total n=21) participate in this sub-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three arms: 12 weeks of 4 mg and 6 mg dapiglutide and placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo (4 mg and 6 mg) | Placebo comparator | Drug: PlaceboAbdominal s.c. self-administration of placebo content once weekly for 12 weeks. To ensure double-blinding, the placebo arm is divided into a 4-mg and 6-mg arm. But both placebo arms are pooled during data analysis. |
| 4 mg dapiglutide | Active comparator | Drug: DapiglutideAbdominal s.c. self-administration of 4 mg dapiglutide once weekly initiated at 2 mg and up-titrated after three weeks until the remaining nine weeks of treatment (12 weeks in total) |
| 6 mg dapiglutide | Active comparator | Drug: DapiglutideAbdominal s.c. self-administration of 6 mg dapiglutide once weekly initiated at 2 mg and up-titrated after three weeks to 4 mg and again to 6 mg after six weeks until the remaining six weeks of treatment (12 weeks in total) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years
- BMI ≥ 30 kg/m²
- History of at least one attempt to lose body weight
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapiglutideAlso: ZP7570GLP-1/GLP-2 receptor agonism | Drug | 4 mg dapiglutide, 6 mg dapiglutide |
| PlaceboPlacebo | Drug | Placebo (4 mg and 6 mg) |
Primary outcome
Percentage change in body weight (kg)
Time frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
4 secondary outcomes
Body weight reduction ≥ 5%
Time frame: From week 0 (baseline) to week 12 (end of treatment)
Body weight reduction ≥ 10%
Time frame: From week 0 (baseline) to week 12 (end of treatment)
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 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 41768273Nielsen CK, Palsson TG, Forman JL, Lukacova M, Jensen BAH, Mathiesen DS, Englund A, Gether IM, Johansen NJ, Pedersen MG, Hartmann B, Holst JJ, Knop FK, Lund AB. Dapiglutide, a dual GLP-1 and GLP-2 receptor agonist, for obesity: a randomised, double-blind, placebo-controlled parallel-group, proof-of-concept trial. EClinicalMedicine. 2026 Feb 21;93:103801. doi: 10.1016/j.eclinm.2026.103801. eCollection 2026 Mar.
- Individual participant dataSharing planned: No. At this moment we do not plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K Knop, MD, PhD principal investigator
Center for Clinical Metabolic Research at Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapiglutide in people with Obesity and Inflammation, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight (kg) (time frame: From week 0 (baseline) to week 12 (end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.