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Active, not recruitingNCT05788601DREAMUpdated Dec 5, 2024

Dapiglutide for the Treatment of Obesity

A Phase 2 interventional study of Dapiglutide and Placebo in Obesity and Inflammation, sponsored by University Hospital, Gentofte, Copenhagen. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by University Hospital, Gentofte, Copenhagen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity
  • Inflammation

Keywords

  • Gut barrier function
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 54 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (estimated)

Study arms

  • Placebo comparator
    Placebo (4 mg and 6 mg)

    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.

    Drug: Placebo

  • Active comparator
    4 mg dapiglutide

    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)

    Drug: Dapiglutide

  • Active comparator
    6 mg dapiglutide

    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)

    Drug: Dapiglutide

Interventions

  • DrugDapiglutide

    GLP-1/GLP-2 receptor agonism

    Also known as: ZP7570

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Percentage change in body weight (kg)

    %-point

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

Secondary outcomes

  1. Body weight reduction ≥ 5%

    count (yes/no)

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

  2. Body weight reduction ≥ 10%

    count (yes/no)

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

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

    %-point

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

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

    %-point

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

Other outcomes

  1. Body weight reduction ≥ 15%

    count (yes/no)

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

  2. Change in BMI (kg/m2)

    %-point

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

  3. Change in systolic blood pressure (mmHg)

    %-point

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

  4. Change in diastolic blood pressure (mmHg)

    %-point

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

  5. Change in resting heart rate (beats per minute)

    %-point

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

  6. Change in body composition as measured by bioimpedance

    %-point

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

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

    %-point

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

  8. Change in FibroScan®-assessed liver fibrosis (kPa)

    %-point

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

  9. Change in Fatty liver index score (FLI)

    %-point (FLI score: Range interval 0-100, \< 30 negative likelihood of fatty liver and \>60 positive likelihood of fatty liver)

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

  10. Change in fibrosis 4 score (FIB-4)

    %-point (score of \<1.30 = low risk; 1.30-2.67 = intermediate risk; \>2.67 = high risk of advanced fibrosis)

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

  11. Change in the 36-Item Short Form Survey

    Score points

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

  12. Change in IWQOL-Lite-CT

    Score points

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

  13. Number of treatment-emergent AEs

    Counts of events

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

  14. Number of serious AEs (SAEs)

    Counts of events

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

07

Study locations

1 site
  • Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
    Hellerup, 2900, Denmark
08

References and documents

Study documents

  • Study protocol · Jan 4, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — At this moment we do not plan to share individual participant data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05788601
Lead sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Zealand Pharma
Responsible party
Filip Krag Knop (Principal Investigator, Clinical Professor, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Mar 29, 2023
Start date
Apr 27, 2023
Primary completion
Apr 24, 2024
Completion
Aug 15, 2025 (estimated)
Last update
Dec 5, 2024

Study contacts

Filip K Knop, MD, PhD
principal investigator · Center for Clinical Metabolic Research at Gentofte Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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