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rimonabant

Phase 3

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

rimonabant development status

Highest phase Phase 3
Registered trials 19 across 1 sponsor since Sep 2005

rimonabant target and mechanism

Molecular targetCNR1
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL111

Also known as rimonabant (SR141716), SR141716, Acomplia

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials19
Total Enrollment18,862

FDA Designations

No designations recorded

rimonabant clinical trials

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 2Unlock trial analytics
PHASE3COMPLETED
Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
ObesityUnlock trial analytics
PHASE3COMPLETED
VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
Metabolic SyndromeUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)
Type 2 Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
DyslipidemiaUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
Type 2 Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
Coronary AtherosclerosisUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch
Smoking CessationUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
ObesityUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients
ObesityUnlock trial analytics

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 has been studied for obesity, metabolic syndrome, dyslipidemia, coronary atherosclerosis, and smoking cessation, including maintenance of smoking cessation. It was also evaluated in overweight or obese patients with type 2 diabetes. These uses were investigated in clinical trials; rimonabant is not approved for marketing.

What does rimonabant target?

Rimonabant targets CNR1, the cannabinoid receptor type 1, acting as an antagonist. By blocking this receptor, it was intended to reduce appetite and modulate metabolic and cardiovascular risk factors. This mechanism was explored across obesity, smoking cessation, and cardiometabolic indications.

Who makes rimonabant?

Rimonabant was developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical development program, including Phase 3 trials in obesity, smoking cessation, and type 2 diabetes.

What phase is rimonabant in?

Rimonabant reached Phase 3 clinical development. Eight trials are registered, all completed, with no active trials. It is an investigational small molecule and has not been approved by the FDA for any indication.

What clinical trials is rimonabant in?

Rimonabant has been studied in completed Phase 3 trials including NCT00546325 (REASSURE) in type 2 diabetes, NCT00481975 in obesity and eating disorders, NCT00481923 in obesity, and NCT00464256 in smoking cessation. Across eight trials, total enrollment was 8,245 participants.

Is rimonabant the same as SR141716?

Yes, rimonabant is also known as SR141716. SR141716 is the compound identifier used for rimonabant, a small molecule CNR1 antagonist developed by Sanofi.