DRUG
Survodutide
once weekly subcutaneous injection
Status
Completed
Phase
Phase 3
Enrollment
274
Locations
28
Results
Not posted
Publications
1
Study summary
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.
Interventions
DRUG
once weekly subcutaneous injection
DRUG
once weekly subcutaneous injection
Timeline
First posted
Dec 19, 2023
Study start
Jan 16, 2024
Primary completion
Dec 3, 2025
Study completion
Dec 3, 2025
Results posted
Not reported
Registry updated
Apr 30, 2026
Outcomes
Percentage change in body weight from baseline to Week 76
Time frame · at baseline, at week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Time frame · at baseline, at week 76
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Time frame · at baseline, at week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Time frame · at baseline, at week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in body weight (kg)
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²)
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in waist circumference measured at umbilical level (cm)
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in waist circumference measured at midway between the lower rib margin and the iliac crest (cm)
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Time frame · at baseline, at week 76
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour Patient reported outcome (PRO)
Time frame · at baseline, at week 76
The "Capacity to Resist domain score" of the Eating Behaviour Patient reported outcome (PRO) (units on a scale) will be derived as the sum of items in the domain (possible responses being 0="Not at all", 1="A little", 2="Moderately", 3="A lot", 4="Extremely"). The domain score is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.
Eligibility
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.
Study locations
Japan. Showing up to 24 locations stored in the fast local snapshot.
Hosokawa Surgery Clinic
Aichi, Nagoya, Japan
Nagoya City University Hospital
Aichi, Nagoya, Japan
Chiba University Hospital
Chiba, Chiba, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Jiyugaoka Yamada Clinic
Hokkaido, Obihiro, Japan
Yamasaki Family Clinic
Hyogo, Amagasaki, Japan
Kobe University Hospital
Hyogo, Kobe, Japan
Motomachi Takatsuka Naika Clinic
Kanagawa, Yokohama, Japan
Morinagaueno Clinic
Kumamoto, Kumamoto, Japan
Yoshimura Clinic
Kumamoto, Kumamoto, Japan
Medical Corporation KEISEIKAI Kajiyama Clinic
Kyoto, Kyoto, Japan
Ijinkai Takeda General Hospital
Kyoto, Kyoto, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
OCROM Clinic
Osaka, Suita, Japan
Saino Clinic
Saitama, Tokorozawa, Japan
Dojinkinenkai Meiwa Hospital
Tokyo, Chiyoda-ku, Japan
Suidoubashi Medical Clinic
Tokyo, Chiyoda-ku, Japan
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, Japan
Tokyo Center Clinic
Tokyo, Chuo-ku, Japan
Fukuwa Clinic
Tokyo, Chuo-ku, Japan
Tokyo Asbo Clinic
Tokyo, Chuo-ku, Japan
New Medical Research System Clinic
Tokyo, Hachioji, Japan
Shimamura Kinen Hospital
Tokyo, Nerima-ku, Japan
Clinical Research Hospital Tokyo
Tokyo, Shinjuku-ku, Japan
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