Influence of single nucleotide polymorphisms of carboxypeptidase D (CPD) gene on body weight and fat mass reduction by perindopril in obese subjects: A phase II, multicenter, double-blind study.

• Register: EUCTR
• Last refreshed on: 8 January 2018
• Main ID: EUCTR2015-004275-70-PT
• Date of registration: 18/12/2015
• Prospective Registration: Yes
• Primary sponsor: Gene PreDiT SA
• Public title: Influence of single nucleotide polymorphisms of carboxypeptidase D (CPD) gene on body weight and fat mass reduction by perindopril in obese subjects: A phase II, multicenter, double-blind study.
• Scientific title: Influence of single nucleotide polymorphisms of carboxypeptidase D (CPD) gene on body weight and fat mass reduction by perindopril in obese subjects: A phase II, multicenter, double-blind study. - Not applicable
• Date of first enrolment: 08/01/2016
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004275-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Portugal

Contacts

• Name: Blueclinical
• Affiliation: Blueclinical - Investigacao e Desenvolvimento em Saude, Lda

• Name: Blueclinical
• Affiliation: Blueclinical - Investigacao e Desenvolvimento em Saude, Lda

Key inclusion & exclusion criteria

Inclusion criteria:
Written informed consent;
Man or woman with 18 years or more;
Body Mass Index (BMI) between 30.0 to 40.0 kg/m2;
Willingness and ability to comply with the study requirements;
Ability to understand and sign informed consent;
If woman of childbearing potential, she agrees to adopt an effective contraceptive method.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
Pregnant or breastfeeding women;
History of obesity with a known cause (e.g., hypothyroidism, Cushing's disease);
Under treatment with perindopril or other angiotensin converting enzyme (ACE) inhibitor, or with an angiotensin receptor blocker (ARB) or a renin inhibitor;
Hypertension diagnosed at screening;
Significant variation in weight (>10%) in the past 3 months before screening visit;
History of anorexia nervosa, bulimia, or binge-eating disorder;
Systolic blood pressure <110 mmHg;
History of hypersensitivity to perindopril, or other ACE inhibitors, or to any of the inactive ingredients;
History of angioedema associated with previous ACE inhibitor therapy;
History of idiopathic or hereditary angioedema;
Treatment with concomitant medication affecting weight loss (e.g. metformin) starting within the 3 months prior to screening;
Treatment with concomitant medication that might interfere with the absorption, distribution, metabolism or elimination of perindopril, or, is likely to compromise the safety of subject (e.g. diuretics in patients with salt and/or volume depletion, insulin or oral antidiabetics in patients prone to develop hypoglycemic episodes, lithium, vasodilators in patients prone to develop hypotension, tricyclic antidepressants, antipsychotics, anesthetics, gold, potassium supplements or potassium-containing salt substitutes);
Treatment with any investigational drug or device within 1 month before the start of the run-in period;
Moderate to severe hepatic impairment (Child-Pugh score = 7) or moderate to severe renal impairment (glomerular filtration rate (GFR) = 59 ml/min);
Unstable coronary artery disease;
Aortic and mitral valve stenosis / hypertrophic cardiomyopathy
Hemodialysis patients;
Kidney transplantation;
Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis;
Neutropenia/agranulocytosis/thrombocytopenia/Anemia;
Patients undergoing major surgery or during anesthesia with agents that produce hypotension;
Hyperkalemia;
Any other condition or therapy that the study physician considers to make the subject unsuitable for this study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

Body weight and fat mass reduction by perindopril in obese subjects

Intervention(s)

Trade Name: Perindopril Bluepharma
Product Name: Perindopril Bluepharma
Product Code: Not applicable. Trade name provided above
Pharmaceutical Form: Tablet
INN or Proposed INN: PERINDOPRIL
Other descriptive name: PERINDOPRIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Body weight, body mass index (BMI), waist and hip circumference, and body fat mass estimation will be assessed at every study visit: 6 weeks after period 2 initiation and the the end of period 2

Primary end point(s): Response rate, defined as the proportion of patients who will lose at least 3% of body weight and/or at least 3% of fat mass from end of the run-in period to the end of the perindopril treatment period.

Main Objective: To evaluate CPD genotyping as a predictive biomarker of body weight and/or fat mass reduction in obese patients treated with perindopril.

Secondary Objective: To assess the association between CPD genotypes/single nucleotide polymorphisms (SNPs) and response to perindopril.
To evaluate the effect of perindopril in waist circumference, waist/hip ratio, and BMI.
To evaluate the tolerability and safety of perindopril in the study population.
To evaluate CPD genotyping as a predictive biomarker of body weight and/or fat mass reduction as per regulatory requirements in obese patients treated with perindopril.

Secondary Outcome(s)

Secondary end point(s): End vs start of treatment relative change in body weight.
End vs start of treatment relative change in fat mass.
End vs start of treatment relative change in waist circumference.
End vs start of treatment relative change in hip circumference.
End vs start of treatment relative change in fasting lipid profile.
Frequency and type of adverse events.
Response rate, defined as the proportion of patients who will lose at least 5% of body weight and/or at least 5% of fat mass from end of the run-in period to the end of the perindopril treatment period.

Timepoint(s) of evaluation of this end point: Body weight, body mass index (BMI), waist and hip circumference, and body fat mass estimation will be assessed at every study visit: 6 weeks after period 2 initiation and the the end of period 2

Secondary ID(s)

GPD-01-01

Source(s) of Monetary Support

Gene PreDiT SA