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A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
A Phase III, Randomized, Double-blind, Parallel-group, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Chinese Participants With a BMI >=28 kg/m2 or BMI >=24 kg/m2 With at Least One Weight-related Complication
Lead sponsor
Asset
Survodutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
28
Recruiting sites
—
Enrollment
307
actual
Study population
Obesity / overweight
Key I/E criteria
•BMI ≥28•HbA1c ≥6.5%
Primary endpoints
•Body weight, % change•≥5% weight-loss responders
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Male or female, age ≥18 years at the time of signing informed consent.
2. Body mass index (BMI) ≥28 kg/m^2 at screening, OR BMI ≥24 kg/m^2 at screening with the presence of at least one of the following weight-related complications:
--- Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i) inhibitor, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
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 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (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 participant information.
Further inclusion criteria apply.
Exclusion criteria
(A) 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 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 (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) (B) Diabetes-related for participants with T2DM:
5. 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, glucagon-like peptide-1 receptor (GLP- 1R)) agonists, GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations, and dipeptidyl peptidase 4 inhibitor (DPP-4i))
6. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial
7. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, verified by an eye examination within 3 months prior to screening or in the period between screening and randomisation Further exclusion criteria apply.
Endpoints (22)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
8 endpointsPercentage change in body weight from baseline to Week 52
Time frame:At baseline and at Week 52.
Body weight, % change
percent change from baseline, improvement
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
Time frame:At baseline and at Week 52.
≥5% weight-loss responders
threshold achievement, improvement
Key secondary endpoint: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52
Time frame:At baseline and at Week 52
≥10% weight-loss responders
threshold achievement, improvement
Key secondary endpoint: Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 52
Time frame:At baseline and at Week 52
≥15% weight-loss responders
threshold achievement, improvement
Key secondary endpoint: Absolute change from baseline to Week 52 in waist circumference (cm)
Time frame:At baseline and at Week 52
Waist circumference, change
change from baseline, improvement
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52
Time frame:At baseline and at Week 52
≥20% weight-loss responders
threshold achievement, improvement
Absolute change from baseline to Week 52 in body weight (kg)
Time frame:At baseline and at Week 52
Body weight, absolute change (kg)
change from baseline, improvement
Absolute change from baseline to Week 52 in body mass index (BMI) (kg/m^2)
Time frame:At baseline and at Week 52
BMI, change
change from baseline, improvement
Glycemic / diabetes
4 endpointsAbsolute change from baseline to Week 52 in glycosylated haemoglobin A1c (HbA1c) (%)
Time frame:At baseline and at Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Absolute change from baseline to Week 52 in HbA1c (mmol/mol)
Time frame:At baseline and at Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Absolute change from baseline to Week 52 in fasting plasma glucose (FPG) (mg/dL)
Time frame:At baseline and at Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Absolute change from baseline to Week 52 in fasting plasma insulin (FPI) (mIU/L)
Time frame:At baseline and at Week 52
change from baseline, improvement
MASH / liver
2 endpointsAbsolute change from baseline to Week 52 in alanine aminotransferase (ALT) (U/L)
Time frame:At baseline and at Week 52
ALT, change
change from baseline, improvement
LOINC 1742-6
Absolute change from baseline to Week 52 in aspartate aminotransferase (AST) (U/L)
Time frame:At baseline and at Week 52
AST, change
change from baseline, improvement
LOINC 1920-8
Cardiometabolic biomarkers
8 endpointsAbsolute change from baseline to Week 52 in systolic blood pressure (SBP) (mmHg)
Time frame:At baseline and at Week 52
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Absolute change from baseline to Week 52 in diastolic blood pressure (DBP) (mmHg)
Time frame:At baseline and at Week 52
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Absolute change from baseline to Week 52 in total cholesterol (mg/dL)
Time frame:At baseline and at Week 52
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Absolute change from baseline to Week 52 in high-density lipoprotein (HDL) cholesterol (mg/dL)
Time frame:At baseline and at Week 52
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Absolute change from baseline to Week 52 in low-density lipoprotein (LDL) cholesterol (mg/dL)
Time frame:At baseline and at Week 52
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Absolute change from baseline to Week 52 in very low-density lipoprotein (VDL) cholesterol (mg/dL)
Time frame:At baseline and at Week 52
VLDL, change
change from baseline, improvement
Absolute change from baseline to Week 52 in triglycerides (mg/dL)
Time frame:At baseline and at Week 52
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Absolute change from baseline to Week 52 in free fatty acids (mg/dL)
Time frame:At baseline and at Week 52
Free fatty acids, change
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.