COR-1 Study

Mysimba® Enhances Diet and Exercise Regimens for Sustained Long-term Weight Loss

In COR-1, patients were advised to follow a reduced-calorie diet, increase physical activity, and participate in behavioural counseling1

  • 62% of patients taking Mysimba® achieved ≥5% weight loss vs 23% taking placebo (completers)1
  • 31% of patients taking Mysimba® achieved ≥5% weight loss vs 12% taking placebo (ITT-BOCF)1

Mean percent weight change over 56 weeks in completers

50.1% in the placebo group and 49.2% in the Mysimba® group discontinued study drug.

ITT=Intention-To-Treat; LOCF=last observation carried forward; LS=least squares; BOCF=baseline observation carried forward; COR=Contrave obesity research.

COR-1 was a 56-week, multicentre, double-blind, placebo-controlled study. Patients were randomised to Mysimba® 32 mg/360 mg daily or placebo. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving ≥5% reduction in body weight at Week 56. Unless noted otherwise, data shown are from the ITT analysis, which included all randomised patients who had body-weight measurements at baseline and at least once post-baseline. LOCF was used for missing data.1,3

Mysimba® ITT: n=538, placebo ITT: n=536. Average baseline parameters were: Mysimba®: 99.8 kg, 109.2-cm waist circumference; placebo: 99.3 kg, 109.2-cm waist circumference. Patients who completed 56 weeks of treatment: Mysimba®: 50.8%; placebo: 49.9%.1

View COR-BMOD results
Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

References:

  1. Mysimba® (naltrexone HCl and bupropion HCl) Summary of Product Characteristics (SmPC).
  2. Data on file.
  3. Greenway FL, Fujioka K, Plodkowski RA, et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376(9741):595-605.