Active, not recruiting
Phase 2
Dapiglutide for the Treatment of Obesity
Condition(s) studied
ObesityInflammation
Investigational drug(s) / intervention(s)
DapiglutidePlacebo
Dapiglutide: GLP-1/GLP-2 receptor agonism
Placebo: Placebo
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.
Eligibility
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
Primary outcome measure(s)
- Percentage change in body weight (kg) — From week 0 (baseline) to week 12 (end of treatment)
%-point
Trial sites (1)
| Facility | City | Region | Status |
| Center for Clinical Metabolic Research, Herlev-Gentofte Hospital |
Hellerup |
Denmark |
|
More University Hospital, Gentofte, Copenhagen trials in Denmark
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