Clinical trial

Dapiglutide for the Treatment of Obesity

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT05788601

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Inflammation

Full registry criteria

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

Treatments and study arms

Dapiglutide

Drug

GLP-1/GLP-2 receptor agonism

Placebo

Drug

Placebo

Primary outcomes

Percentage change in body weight (kg)From week 0 (baseline) to week 12 (end of treatment)

%-point

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital🇩🇰 Hellerup, Denmark