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Rimonabant

Phase 3

Coronary Atherosclerosis | Small molecule | Cardiovascular |Sanofi|Last Updated: Jun 6, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment839

FDA Designations

No designations recorded

Clinical trial landscape

Rimonabant · 19 trials · 12 indications

Phase 3 18Phase 2 1
NCT00546325REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic AgentsDiabetes Mellitus, Type 2
COMPLETED358 Analytics
NCT00325546Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)Obesity
COMPLETED643 Analytics
NCT00299325VIsceral Fat Reduction Assessed by CT-scan On RImonabAntMetabolic Syndrome
COMPLETED254 Analytics
NCT00288236Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)Type 2 Diabetes Mellitus
COMPLETED368 Analytics
NCT00239967An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese PatientsDyslipidemia
COMPLETED803 Analytics
NCT00257257Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic PatientsType 2 Diabetes Mellitus
COMPLETED281 Analytics
NCT00124332STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)Coronary Atherosclerosis
COMPLETED839 Analytics
NCT00458718Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine PatchSmoking Cessation
COMPLETED755 Analytics
NCT00481975Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese PatientsObesity
COMPLETED289 Analytics
NCT00481923Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese PatientsObesity
COMPLETED156 Analytics
PHASE3COMPLETED
REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
Diabetes Mellitus, Type 2
NCT00546325358
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PHASE3COMPLETED
Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
Obesity
NCT00325546643
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PHASE3COMPLETED
VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
Metabolic Syndrome
NCT00299325254
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PHASE3COMPLETED
Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)
Type 2 Diabetes Mellitus
NCT00288236368
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PHASE3COMPLETED
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
Dyslipidemia
NCT00239967803
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PHASE3COMPLETED
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
Type 2 Diabetes Mellitus
NCT00257257281
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PHASE3COMPLETED
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
Coronary Atherosclerosis
NCT00124332839
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PHASE3COMPLETED
Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch
Smoking Cessation
NCT00458718755
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PHASE3COMPLETED
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
Obesity
NCT00481975289
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PHASE3COMPLETED
Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients
Obesity
NCT00481923156
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Study Endpoints

Primary Endpoints

Absolute change in HbA1c between both placebo and rimonabant group.
From baseline to week 48
Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
From the beginning to the end of the study
Percentage of participants responding to treatment
From the beginning to the end of study
Rate of asymptomatic, symptomatic, and severe hypoglycaemia
From the beginning to the end of the study
Change in physical examinations, vital signs, laboratory parameters, adverse events
From the beginning to the end of the study
Absolute change in weight from baseline to month 9
Relative change in visceral fat area assessed by CT scan
From baseline to Month 12
Absolute change in HbA1C from baseline to Week 48
HDL cholesterol and TG plasma levels over a period of one year.
Absolute change in HbA1C from baseline to Month 6.
change from baseline in percent atheroma volume (PAV)
Month 18 visit
Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements
Change in body weight from baseline to Day 180 visit
Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day
Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.
change in body weight from baseline to 1 year.
Change in body weight
Change from baseline in body weight at 1 year.
absolute change in body weight from baseline to Week 24

Secondary Endpoints

Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
From the beginning to the end of the study
Change in BMI, waist and hip circumference, waist/hip ratio, weight
From the beginning to the end of the study
Changes in Quality of Life
From the beginning to the end of the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRimonabant
2PLACEBO_COMPARATORPlacebo
RimonabantEXPERIMENTALRimonabant 20 mg once daily with mild hypocaloric diet
PlaceboPLACEBO_COMPARATORPlacebo (for Rimonabant) once daily with mild hypocaloric diet

Interventions

NameTypeDescription
RimonabantDRUGWhite opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
PlaceboDRUGMatching placebo tablets. Once daily before breakfast
Rimonabant (SR141716)DRUG -
Placebo (for Rimonabant)DRUGTablet, oral administration
Mild hypocaloric dietOTHERCalculated by the dietitian based on the estimated basal metabolism rate and the physical activity
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

List of Inclusion and Exclusion criteria: Inclusion Criteria: * History of Type 2 diabetes * HbA1c between 7% to 9% (inclusive) * BMI ≥ 27kg/m² and BMI ≤ 40kg/m² * Currently taking Metformin and Sulfonylurea. Exclusion Criteria: * Uncontrolled serious psychiatric illness such as major depression...

Countries:AustraliaChinaSouth KoreaTaiwanUnited StatesCanadaDenmarkFinlandFranceItalySpainSwedenUnited KingdomArgentinaChileGermanyNetherlandsRussiaSouth AfricaBrazilHong KongMalaysiaMexicoSingaporeHungaryPolandBelgiumPortugalSwitzerlandCzechiaJapan
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Frequently asked questions about Rimonabant

What is Rimonabant used for?

Rimonabant is an investigational small molecule being developed for obesity, maintenance of smoking cessation, metabolic syndrome, coronary atherosclerosis, dyslipidemia, and type 2 diabetes mellitus. It is in Phase 3 clinical development and has not been approved by the FDA.

Who makes Rimonabant?

Rimonabant is being developed by Sanofi, a company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical trials for multiple indications including obesity and smoking cessation.

What phase is Rimonabant in?

Rimonabant is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. All eight clinical trials for Rimonabant have been completed, with no active trials currently ongoing.

What clinical trials is Rimonabant in?

Rimonabant has completed eight Phase 3 clinical trials with a total enrollment of 8,245 participants. These include trials such as NCT00358228, NCT00458718, NCT00464165, and NCT00464256, which studied the drug as an aid to smoking cessation in various countries.

Is Rimonabant the same as Acomplia?

Rimonabant is also known by the brand name Acomplia. It is an investigational small molecule being developed by Sanofi for obesity and other metabolic conditions. The drug is in Phase 3 development and is not FDA approved.