COMBINATION_PRODUCT
survodutide
once weekly subcutaneous injection
Status
Completed
Phase
Phase 3
Enrollment
726
Locations
118
Results
Not posted
Publications
2
Study summary
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.
Interventions
COMBINATION_PRODUCT
once weekly subcutaneous injection
COMBINATION_PRODUCT
once weekly subcutaneous injection
Timeline
First posted
Oct 4, 2023
Study start
Nov 25, 2023
Primary completion
Dec 2, 2025
Study completion
Feb 20, 2026
Results posted
Not reported
Registry updated
Mar 12, 2026
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
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 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 the 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.
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
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)
Time frame · Baseline and at Week 76
Eligibility
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) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,: * Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) * Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (HDL) cholesterol \<40 mg/dL (\<1.0 mmol/L) for men or HDL cholesterol 50 mg/dL (\<1.3 mmol/L) for women) * Obstructive sleep apnoea * Others. 3. 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. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening. 4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit. 5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV. 6. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction). 7. History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase \>2x upper limit of normal (ULN) as measured by the central laboratory at screening. 8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). Further exclusion criteria apply.
Study locations
Australia · Belgium · Canada · China · Finland · Germany · Japan · Netherlands · New Zealand · Poland · South Korea · Sweden · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
EmVenio Research-Phoenix-69743
Phoenix, Arizona, United States
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Yale University School of Medicine
New Haven, Connecticut, 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
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
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
Lucas Research, Inc.
Morehead City, North Carolina, United States
Accellacare-Wilmington-67123
Wilmington, North Carolina, United States
Valley Weight Loss Clinic
Fargo, North Dakota, United States
Publications
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