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.

Phase 1

• Conditions: Body weight and fat mass reduction by perindopril in obese subjects; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2015-004275-70-PT
• Lead Sponsor: Gene PreDiT SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-18
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified