Dapiglutide for the Treatment of Obesity

What Was Tested

This registered phase 2 trial tested Dapiglutide.

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.

It had three arms (groups): one (placebo comparator), one (active comparator) and one (active 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.

The registry classes the interventions as drug.

More on the Plan

The IMP is subcutaneously administered in the abdomen once weekly from week 0 (V2) until week 12 (V14).

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.

Who Took Part

Enrollment: 54 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 18-75 years. BMI ≥ 30 kg/m². History of at least one attempt to lose body weight.

The full record lists 3 inclusion and 30 exclusion criteria; among the exclusions: 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; history of type 1 diabetes or type 2 diabetes.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Dapiglutide group and the comparison group should start out alike.

The Dapiglutide group and the comparison group ran side by side rather than switching.

As a double-blind Dapiglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2023-04-27 with completion listed for 2024-04-24.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage change in body weight (kg) (time frame: From week 0 (baseline) to week 12 (end of treatment)).

It also tracked 4 secondary outcomes, for example Change in fasting serum/plasma concentrations of gut permeability biomarker (LPS-binding protein (LBP)) and Change in fasting serum/plasma concentrations of inflammation markers (hs-CRP and IL-6).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dapiglutide in 54 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dapiglutide compound page, all human trials.