Dapiglutide for the Treatment of Obesity (DREAM)

December 4, 2024 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
GLP-1/GLP-2 receptor agonism
Other Names:
  • ZP7570
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
GLP-1/GLP-2 receptor agonism
Other Names:
  • ZP7570

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change in body weight (kg)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight reduction ≥ 5%
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
count (yes/no)
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)
count (yes/no)
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)
%-point
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)
%-point
From week 0 (baseline) to week 12 (end of treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight reduction ≥ 15%
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
count (yes/no)
From week 0 (baseline) to week 12 (end of treatment)
Change in BMI (kg/m2)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in systolic blood pressure (mmHg)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in diastolic blood pressure (mmHg)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in resting heart rate (beats per minute)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in body composition as measured by bioimpedance
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in FibroScan®-assessed liver steatosis (dB/m)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in FibroScan®-assessed liver fibrosis (kPa)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point
From week 0 (baseline) to week 12 (end of treatment)
Change in Fatty liver index score (FLI)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point (FLI score: Range interval 0-100, < 30 negative likelihood of fatty liver and >60 positive likelihood of fatty liver)
From week 0 (baseline) to week 12 (end of treatment)
Change in fibrosis 4 score (FIB-4)
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
%-point (score of <1.30 = low risk; 1.30-2.67 = intermediate risk; >2.67 = high risk of advanced fibrosis)
From week 0 (baseline) to week 12 (end of treatment)
Change in the 36-Item Short Form Survey
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
Score points
From week 0 (baseline) to week 12 (end of treatment)
Change in IWQOL-Lite-CT
Time Frame: From week 0 (baseline) to week 12 (end of treatment)
Score points
From week 0 (baseline) to week 12 (end of treatment)
Number of treatment-emergent AEs
Time Frame: From signed consent form (week -3) to follow-up visit (week 16)
Counts of events
From signed consent form (week -3) to follow-up visit (week 16)
Number of serious AEs (SAEs)
Time Frame: From signed consent form (week -3) to follow-up visit (week 16)
Counts of events
From signed consent form (week -3) to follow-up visit (week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Gentofte, Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zealand Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Filip K Knop, MD, PhD, Center for Clinical Metabolic Research at Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The 'DREAM' trial
  • 2022-501649-54-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this moment we do not plan to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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