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A study investigating rimonabant versus placebo in conjunction with a strict low-fat weight reduction diet in overweight and obese subjects: effects on glucose and lipid metabolism and cardiovascular risk.

A study investigating rimonabant versus placebo in conjunction with a strict low-fat weight reduction diet in overweight and obese subjects: effects on glucose and lipid metabolism and cardiovascular risk.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001003-38-GB
Enrollment
Unknown
Registered
2008-06-17
Start date
2008-08-01
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study will investigate subjects who are overweight and obese with Body Mass Index >27kg/m2. MedDRA version: 9.1 Level: LLT Classification code 10022489 Term: Insulin resistance

Interventions

Trade Name: Rimonabant 20mg Product Name: Rimonabant Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

The Royal Group of Hospitals, Belfast Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - BMI >27kg/m2 - Age >18 years old 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Significant cardiac, renal or hepatic disease - History of depression or anxiety - Women of childbearing potential unless on appropriate contraception - Pregnant women - Already using pharmacotherapy to induce weight loss

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objective of the trial is to assess insulin resistance and weight loss following the 8 week period of rimonabant/placebo and diet.;Secondary Objective: Secondary objectives will include the measurement of glycaemic control, insulin secretion, plasma lipid and adipokines, vascular compliance, body composition and fat biopsy analysis;Primary end point(s): Insulin resistance measured by hyperinsulinaemic euglycaemic glucose clamps (baseline and end).—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026