Dapiglutide for the Treatment of Obesity

• Status: Not yet recruiting
• Trial end date: 2024-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborator: Zealand Pharma

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