NCT02777489: GPD-01-01

Influence of Carboxypeptidase D (CPD) Gene on Body Weight and Fat Mass Reduction by Perindopril in Obese Subjects

Terminated Phase 2 Last updated 3 August 2017

What this trial tests

Phase 2 trial testing Perindopril in Obesity in 140 participants. Terminated before completion.

Timeline

18 February 2016

Primary endpoint
18 January 2017

27 April 2017

Quick facts

Lead sponsor	Gene PreDiT
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	140
Start date	18 February 2016
Primary completion	18 January 2017
Estimated completion	27 April 2017
Sites	13 locations across Portugal

Drugs / interventions tested

• Perindopril — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Gene PreDiT

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to evaluate the Carboxipeptidase D (CPD) genotyping as a predictive biomarker of body weight and/or fat mass reduction in obese patients treated with perindopril.

There is nonclinical and clinical evidence that a subgroup of human subjects may present a decrease in body weight and/or fat mass following treatment with perindopril. Although the individual characteristics that determine such effect are still unknown, Gene PreDiT SA (Biocant Park, Cantanhede, Portugal) discovered that certain genetic characteristics (e.g., single nucleotide polymorphisms (SNPs) of CPD gene) may play a role and potentially could serve as a potential predictive biomarker of response to perindopril.

These promising results, along with the fact that perindopril is a medicine already in use in clinical practice, led Gene PreDiT SA to decide to proceed with the development of a theranostic approach for the treatment of obesity. Such theranostic approach consists on the use of CPD genotyping to identify obese subjects that could present improved body weight and fat mass reduction following treatment with perindopril.

The current clinical trial aims to prove the concept and provide data to design further confirmatory studies. Additionally this study will evaluate the association between CPD SNPs genotypes and response to perindopril; the effect of perindopril in waist circumference, waist/hip ratio, and BMI and the tolerability and safety of perindopril in the study population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.