1404-0038

• Research type

  Research Study

• Full title

  A Phase 3, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity without type 2 diabetes

• IRAS ID

  1008590

• Contact name

  Medical Information

• Contact email

  medinfo.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Limited

• Research summary

  A study to test whether BI 456906 helps people living with overweight or obesity who do not have diabetes to lose weight
  This study is open to adults who are at least 18 years old and have

  a body mass index (BMI) of 30 kg/m2 or more, or

  a BMI of 27 kg/m2 or more and at least one health problem related to their weight.

  People with type 2 diabetes cannot take part in this study. Only people who have previously

  not managed to lose weight by changing their diet can participate.

  The purpose of this study is to find out whether a medicine called survodutide (BI 456906)

  helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain

  any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In

  addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.

  Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.

  The doctors check participants’ health and take note of any unwanted effects. The participants’ body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  23/LO/0867

• Date of REC Opinion

  13 Nov 2023

• REC opinion

  Further Information Favourable Opinion