ObesityPhase 3NCT00408148
High Density Lipoprotein Turnover
A Phase 3 study testing Rimonabant in people with Obesity, run by Sanofi at 4 sites in 4 countries.
Trial summary
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period. Primary objectives: To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominally obese patients with additional cardiometabolic risk factors
- Females must be post-menopausal
- BMI > 27 kg/m² and < 40 kg/m²
- Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men
- With at least one lipid abnormality defined as:
- Fasting Triglycerides level > 1.7 mmol/L (150 mg/dL) and < 4.5 mmol/L (400 mg/dL)
- HDL < 1.03 mmol/L (40 mg/dL) in men and < 1.29 mmol/L (50 mg/dL) in women
Who cannot join
- HDL ≤ 0.60 mmol/L (23 mg/dl)
- Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia
- Fasting triglycerides > 400 mg/dL (4.5 mmol/L)
- Known heterozygous or homozygous familial hypercholesterolaemia or know type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
- Type 2 diabetes treated with oral agents and/or insulin
Show all 40Show fewer
- Diet treated type 2 diabetic patients with HbA1c ≥ 7%
- History of cardio vascular disease
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg.
- Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
- Body weight fluctuation > 5 Kg during the previous 3 months
- History of bulimia or anorexia nervosa by DSM-IV criteria
- Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder.
- Abnormal TSH and free T4 at baseline (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status.)
- Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening.
- Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
- Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study
- Patient treated for epilepsy
- Ongoing major depressive illness
- Uncontrolled psychiatric illness
- History of alcohol and/or drug abuse
- Smoker or smoking cessation within the past 3 months
- Marijuana or hashish users
- Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
- Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
- Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing
- Recent history of active peptic ulcer
- Willebrand disease or other hemorrhagic diatheses
- Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period:
- Lipid-lowering drugs intake
- Anti obesity drugs
- Other drugs for weight reduction (phentermine, amphetamines)
- Herbal preparations for weight reduction
- Other drugs known to affect lipid metabolism: retinoids, antiretroviral, estrogens and hormone replacement therapy, cyclosporine, glitazones, benfluorex, fish oils, plant sterols.
- Thiazids (including fixed combination) at daily dose higher than 12.5 mg
- Unselective beta-blockers
- Prolonged use (more than one week) of systemic corticosteroids, neuroleptics
- Anticoagulants
- Ongoing antidepressive treatment
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Randomized, Double-blind, Two Arm, Parallel, Placebo Controlled Study of Rimonabant 20 mg Effect on High Density Lipoprotein Kinetics in Patients With Abdominal Obesity and Additional Cardiometabolic Risk Factors
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.
Primary objectives:
- To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).
Secondary objectives:
- To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
- To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
- To assess effect of Rimonabant on body composition
- To assess safety of Rimonabant
- Conditions
- Obesity
- Being tested
- Placebo, Rimonabant
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Undistinguishable placebo tablets
RimonabantDrug
White film-coated, for oral administration containing 20 mg of active rimonabant
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Administration of one rimonabant placebo tablet once daily in the morning Receives: Drug: Placebo |
| 1 | Experimental | Administration of one tablet containing 20 mg of active rimonabant once daily in the morning Receives: Drug: Rimonabant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fractional catabolic rate (FCR) of HDL ApoA-I
Measured: After 12 months of treatment.
Secondary outcomes (12)
Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II
Measured: All across the study
PR and FCR of VLDL1 and VLDL2 Apo B, VLDL1 and VLDL2 TG, IDL Apo B and LDL Apo B
Measured: All across the study
Variation in ApoA-I, ApoA-II, Lp-AI, Lp-AII, pre-beta-HDL HDL2a, HDL2b, HDL3a, HDL3b, HDL3c, Apo B, Apo C III, TG, LDL-C, HDL-C levels
Measured: All across the study
Variation in Glucose, insulin, HbA1c, leptin, adiponectin
Measured: All across the study
Variation in hs-CRP, TNF-alpha, CETP, PLTP and LCAT activities, lipoprotein and hepatic lipase activities in post-heparin plasma
Measured: All across the study
Variation in whole body fat
Measured: All across the study
Variation in abdominal sub-cutaneous and visceral fat
Measured: All across the study
Variation in liver fat
Measured: All across the study
Variation in blood pressure
Measured: All across the study
Variation in body weight, waist circumference, waist/hip ratio
Measured: From the beginning to the end of the study
CE/TG ratio in HDL
Measured: All across the study
Adverse events
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Company decision has been taken in light of recent demands by certain national health authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408148
- Sponsor's protocol ID
- RIMON_C_01346
- Other IDs
- EUDRACT # : 2006-001716-71
- Status last verified
- Dec 2010
- First submitted
- 5 Dec 2006
- Last updated
- 10 Dec 2010
- Results posted
- No
Publications
Verges B, Adiels M, Boren J, Barrett PH, Watts GF, Chan D, Duvillard L, Soderlund S, Matikainen N, Kahri J, Robin I, Taskinen MR. Interrelationships between the kinetics of VLDL subspecies and HDL catabolism in abdominal obesity: a multicenter tracer kinetic study. J Clin Endocrinol Metab. 2014 Nov;99(11):4281-90. doi: 10.1210/jc.2014-2365. Epub 2014 Jul 31.
PubMed 25077901
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Two Arm, Parallel, Placebo Controlled Study of Rimonabant 20 mg Effect on High Density Lipoprotein Kinetics in Patients With Abdominal Obesity and Additional Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT00408148
- Acronym / sponsor ID
- RIMON_C_01346
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision has been taken in light of recent demands by certain national health authorities
- Enrolment
- 64 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period.
Primary objectives:
- To assess effect of Rimonabant on HDL ApoA-I fractional catabolic rate (FCR).
Secondary objectives:
- To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
- To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
- To assess effect of Rimonabant on body composition
- To assess safety of Rimonabant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: PlaceboAdministration of one rimonabant placebo tablet once daily in the morning |
| 1 | Experimental | Drug: RimonabantAdministration of one tablet containing 20 mg of active rimonabant once daily in the morning |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Abdominally obese patients with additional cardiometabolic risk factors
- Females must be post-menopausal
- BMI > 27 kg/m² and < 40 kg/m²
- Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men
- With at least one lipid abnormality defined as:
Key exclusion criteria (40 listed)
- HDL ≤ 0.60 mmol/L (23 mg/dl)
- Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia
- Fasting triglycerides > 400 mg/dL (4.5 mmol/L)
- Known heterozygous or homozygous familial hypercholesterolaemia or know type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboUndistinguishable placebo tablets | Drug | 2 |
| RimonabantWhite film-coated, for oral administration containing 20 mg of active rimonabant | Drug | 1 |
Primary outcome
The fractional catabolic rate (FCR) of HDL ApoA-I
Time frame: After 12 months of treatment.
12 secondary outcomes
Production Rate (PR) of HDL ApoA-I and A-II, (FCR) of HDL ApoA-II
Time frame: All across the study
PR and FCR of VLDL1 and VLDL2 Apo B, VLDL1 and VLDL2 TG, IDL Apo B and LDL Apo B
Time frame: All across the study
Variation in ApoA-I, ApoA-II, Lp-AI, Lp-AII, pre-beta-HDL HDL2a, HDL2b, HDL3a, HDL3b, HDL3c, Apo B, Apo C III, TG, LDL-C, HDL-C levels
Time frame: All across the study
Variation in Glucose, insulin, HbA1c, leptin, adiponectin
Time frame: All across the study
Variation in hs-CRP, TNF-alpha, CETP, PLTP and LCAT activities, lipoprotein and hepatic lipase activities in post-heparin plasma
Time frame: All across the study
Variation in whole body fat
Time frame: All across the study
Variation in abdominal sub-cutaneous and visceral fat
Time frame: All across the study
Variation in liver fat
Time frame: All across the study
Variation in blood pressure
Time frame: All across the study
Variation in body weight, waist circumference, waist/hip ratio
Time frame: From the beginning to the end of the study
CE/TG ratio in HDL
Time frame: All across the study
Adverse events
Time frame: From the beginning to the end of the study
Results and safety
The study was stopped early (reason given: Company decision has been taken in light of recent demands by certain national health authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
- Derived from this study: PubMed 25077901Verges B, Adiels M, Boren J, Barrett PH, Watts GF, Chan D, Duvillard L, Soderlund S, Matikainen N, Kahri J, Robin I, Taskinen MR. Interrelationships between the kinetics of VLDL subspecies and HDL catabolism in abdominal obesity: a multicenter tracer kinetic study. J Clin Endocrinol Metab. 2014 Nov;99(11):4281-90. doi: 10.1210/jc.2014-2365. Epub 2014 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Pilorget study director
Sanofi
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant in people with Obesity, run by Sanofi at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Finland, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision has been taken in light of recent demands by certain national health authorities). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fractional catabolic rate (FCR) of HDL ApoA-I (time frame: After 12 months of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010; AzTrials last refreshed its copy on 26 Oct 2026.