COMBINATION_PRODUCT
Survodutide
once weekly subcutaneous injection, pre-filled syringe
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Status
Completed
Phase
Phase 3
Enrollment
755
Locations
143
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. 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 who also have diabetes 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 study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
Interventions
Treatment arms and agents.
COMBINATION_PRODUCT
Placebo
once weekly subcutaneous injection, pre-filled syringe
Timeline
From registration to results.
First posted
Oct 4, 2023
Study start
Nov 27, 2023
Primary completion
Dec 12, 2025
Study completion
Mar 27, 2026
Results posted
Not reported
Registry updated
Jun 24, 2026
Outcomes
What the study measures.
Primary outcomes
Percentage change in body weight from baseline to Week 76
Time frame · Baseline and at Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Time frame · Baseline and at Week 76
Secondary outcomes
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
Time frame · Baseline and at Week 76
Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
Time frame · Baseline and at Week 76
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
Time frame · Baseline and at Week 76
Absolute change from baseline to Week 76 in body weight (kg)
Time frame · Baseline and at Week 76
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)
Time frame · Baseline and at Week 76
Absolute change from baseline to Week 76 in waist circumference (cm)
Time frame · Baseline and at Week 76
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)
Time frame · Baseline and at Week 76
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)
Time frame · Baseline and at Week 76
"Capacity to Resist" domain score of the Eating Behaviour PRO is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.
Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Time frame · Baseline and at Week 76
Eating Behaviour PRO total score is ranging between 0 and 48 and a higher score indicates a worse eating behaviour (greater desire to eat and/or lower capacity to resist).
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)
Time frame · Baseline and at Week 76
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. 2. Body mass index (BMI) ≥27 kg/m\^2 at screening. 3. Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening. 4. HbA1c ≥6.5% (≥48 mmol/mol) and \<10% (\<86 mmol/mol) as measured by the central laboratory at screening. 5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines. 6. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply. Exclusion Criteria: 1. Body weight change (self-reported) of \>5% within 3 months before screening. 2. Treatment with any medication for the indication obesity within 3 months before screening. 3. Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor \[DPP-4il). 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). 5. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase \>2x upper limit of normal (ULN)) as measured by the central laboratory at screening. 6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). Further exclusion criteria apply.
Study locations
143 registered sites.
Australia · Belgium · Canada · China · Czechia · Denmark · Finland · Germany · Greece · Hungary · Japan · Netherlands · New Zealand · Poland · South Korea · Spain · Sweden · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
EmVenio Research-Atlanta-69582
Phoenix, Arizona, United States
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC - Doral
Doral, Florida, United States
University of Florida
Gainesville, Florida, United States
East Coast Institute for Research, LLC - Jacksonville
Jacksonville, Florida, United States
New Horizon Research Center-Miami-69732
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Emory University
Atlanta, Georgia, United States
East-West Medical Research
Honolulu, Hawaii, United States
Solaris Clinical Research
Meridian, Idaho, United States
Evanston Premier Healthcare Research LLC
Skokie, Illinois, United States
Velocity Clinical Research-Valparaiso-68883
Valparaiso, Indiana, United States
Velocity Clinical Research-Sioux City-69728
Sioux City, Iowa, United States
AMR Lexington
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
StudyMetrix Research, LLC
City of Saint Peters, Missouri, United States
Walgreens Clinical Trials-Atlantic City-69647
Atlantic City, New Jersey, United States
Walgreens - Perth Amboy - Site 4544
Perth Amboy, New Jersey, United States
Premier Research, Inc.
Trenton, New Jersey, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, United States
Southgate Medical Group/ Southgate Medical Park
West Seneca, New York, United States
Physicians East, PA
Greenville, North Carolina, United States
Related trials
More studies on Survodutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
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A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
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A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
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LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis (MASH) · Liver Fibrosis
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LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
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A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Completed
56
2026-06
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
64
2026-05
A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
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Phase 3
Completed
274
2026-04
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