A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease

A Phase III, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of Survodutide Administered Subcutaneously Compared With Placebo in Patients With Obesity Disease in Japanese

This study is open to adults who are at least 18 years old and have

• a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or
• a BMI of 27 kg/m² or more and at least two health problems related to their weight.

People who have either type 2 diabetes, high blood pressure, or increased blood lipids can 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 obesity disease 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.

Inclusion criteria:

1. Male or female, age ≥18 years at the time of signing informed consent

2. Body Mass Index (BMI)

   • ≥35 kg/m² at screening with the presence of at least one obesity-related comorbidities (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline OR

   • BMI ≥27 kg/m² at screening with the presence of at least two obesity-related comorbidities (treated or untreated) according to the JASSO guideline For all trial patients, at least one co-morbidity should be the following (i)-(iii).

     i. Type 2 diabetes mellitus (T2DM)

     • Diagnosed with T2DM (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening
     • HbA1c ≥6.5% (48 mmol/mol) and <10% (86 mmol/mol) as measured by the central laboratory at screening
     • Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 antihyperglycaemia medications (metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone) according to local label ii. Hypertension iii. Dyslipidaemia

3. History of at least one self-reported unsuccessful dietary effort to lose body weight

4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

5. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the patient information.

6. In the investigator's opinion, patients are well-motivated, capable, and willing to:

   • Learn how to self-inject the Investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP) OR
   • Inject the IMP or accept injection from a designated person
   • Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise and exercise plan), maintain a diary, and complete required questionnaires, and handle the IMP as described in the instructions for use (IFU)

Exclusion criteria:

Obesity:

1. Body weight change (self-reported) >5% within 3 months before screening

2. Treatment with any medication for the indication obesity within 3 months before screening

3. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the gastrointestinal (GI) tract that could interfere with body weight The following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening, (2) lap banding, if the band has been removed >1 year before screening, (3) intragastric balloon, if the balloon has been removed >1 year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed >1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy.

4. Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)

   Glycaemia:

   For trial patients without T2DM:

5. History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening

   For trial patients with T2DM:

6. History of T1DM

7. Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before screening (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and DPP-4i)

8. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial

Further exclusion criteria apply.