Dapiglutide for the Treatment of Obesity

NCT05788601 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: The 'DREAM' trial2022-501649-54-00
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Inflammation

Keywords

Gut barrier function

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight (kg)

  %-point

  From week 0 (baseline) to week 12 (end of treatment)

Secondary Outcomes (4)

• Body weight reduction ≥ 5%

  From week 0 (baseline) to week 12 (end of treatment)

• Body weight reduction ≥ 10%

  From week 0 (baseline) to week 12 (end of treatment)

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

  From week 0 (baseline) to week 12 (end of treatment)

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

  From week 0 (baseline) to week 12 (end of treatment)

Other Outcomes (14)

• Body weight reduction ≥ 15%

  From week 0 (baseline) to week 12 (end of treatment)

• Change in BMI (kg/m2)

  From week 0 (baseline) to week 12 (end of treatment)

• Change in systolic blood pressure (mmHg)

  From week 0 (baseline) to week 12 (end of treatment)

Study Arms (3)

Placebo (4 mg and 6 mg)

PLACEBO COMPARATOR

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

4 mg dapiglutide

ACTIVE COMPARATOR

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

6 mg dapiglutide

ACTIVE COMPARATOR

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

Dapiglutide DRUG

GLP-1/GLP-2 receptor agonism

Also known as: ZP7570

4 mg dapiglutide; 6 mg dapiglutide

Placebo DRUG

Placebo

Placebo (4 mg and 6 mg)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Zealand Pharma: collaborator

Study Sites (1)

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Filip K Knop, MD, PhD

  Center for Clinical Metabolic Research at Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To ensure blinding, the placebo arm is split between 4 mg and 6 mg placebo, making the randomisation sequence 2:2:1:1 (e.i. 2x 4 mg dapiglutide, 2x 6 mg dapiglutide, 1x 4 mg placebo and 1x 6 mg placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Three arms: 12 weeks of 4 mg and 6 mg dapiglutide and placebo

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 29, 2023
• Study Start: April 27, 2023
• Primary Completion: April 24, 2024
• Study Completion: August 15, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)