Phase
Condition
Diabetes Prevention
Obesity
Hypertriglyceridemia
Treatment
Placebo matching BI 456906
BI 456906
survodutide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, age ≥18 years at the time of signing informed consent.
Body mass index (BMI) ≥28 kg/m^2 at screening, OR BMI ≥24 kg/m^2 at screening withthe presence of at least one of the following weight-related complications:
Hypertension (defined as repeated, i.e. at least 3 measurements in restingcondition, systolic blood pressure (SBP) values of ≥140 mmHg and/or diastolicblood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensivetreatment, or intake of at least 1 anti-hypertensive drug to maintain anormotensive blood pressure)
Dyslipidaemia (defined as at least 1 lipid-lowering treatment required tomaintain normal blood lipid levels, or low density lipoprotein (LDL)cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7mmol/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
Cardiovascular disease (CVD) (e.g. heart failure (HF) with New York HeartAssociation (NYHA) functional class II-III, history of ischaemic orhaemorrhagic stroke or cerebrovascular revascularisation procedure [e.g.carotid endarterectomy and/or stent], myocardial infarction (MI), coronaryartery disease, or peripheral vascular disease)
Type 2 diabetes mellitus (T2DM) diagnosed at least 180 days prior to screening (glycosylated haemoglobin A1c (HbA1c) ≥6.5% (48 mmol/mol) and <10% (86mmol/mol), and fasting plasma glucose (FPG) ≤11.1 mmol/L measured by thecentral laboratory at screening --- Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucosecotransporter-2 inhibitor (SGLT2i) inhibitor, acarbose, sulfonylurea, orglitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to locallabel
Non-alcoholic steatohepatitis (NASH), as assessed in medical records byhistological liver assessment (within the last 6 months)
History of at least one self-reported unsuccessful dietary effort to lose bodyweight
Signed and dated written informed consent in accordance with International Councilfor Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-GoodClinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Woman of childbearing potential (WOCBP) must be ready and able to use highlyeffective methods of birth control per ICH M3 (R2) that result in a low failure rateof less than 1% per year when used consistently and correctly. A list ofcontraception methods meeting these criteria and instructions on the duration oftheir use will be provided in the participant information.
Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
(A) Obesity:
Body weight change (self-reported) >5% within 3 months before screening.
Treatment with any medication for the indication obesity within 3 months beforescreening.
Previous or planned (during the trial period) treatment for obesity with surgery ora weight loss device, or prior surgery of the GI tract that could interfere withbody weight The following are allowed: (1) liposuction and/or abdominoplasty, ifperformed >1 year before screening, (2) lap banding, if the band has been removed >1year before screening, (3) intragastric balloon, if the balloon has been removed >1year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has beenremoved >1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7)cholecystectomy
Have obesity induced by other endocrinologic disorders (for example, CushingSyndrome) 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:
Treatment with any medication for the indication of T2DM other than stated in theinclusion criteria within 3 months before screening (i.e. insulin, amylin analogues,glucagon-like peptide-1 receptor (GLP- 1R)) agonists, GLP-1Ragonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations, anddipeptidyl peptidase 4 inhibitor (DPP-4i))
New initiation of any other glucose-lowering investigational drug within 3 monthsprior to screening for this trial
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, verifiedby an eye examination within 3 months prior to screening or in the period betweenscreening and randomisation Further exclusion criteria apply.
Study Design
Connect with a study center
Beijing Chao-Yang Hospital
Beijing, 100020
ChinaSite Not Available
Beijing Pinggu Hospital
Beijing, 101200
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
The Second Hospital of Jilin University
Changchun, 130041
ChinaSite Not Available
Changzhou Second People's Hospital
Changzhou, 213004
ChinaSite Not Available
People's Hospital of Sichuan Province
Chengdu, 610072
ChinaSite Not Available
Second Affiliated Hospital Chongqing Medical University
Chongqing, 400016
ChinaSite Not Available
NanFang Hosptial
Guangzhou, 510515
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Hangzhou, 210011
ChinaSite Not Available
Forth Clinical Hospital of Harbin Medical University
Harbin, 150599
ChinaSite Not Available
Huzhou Central Hospital
Huzhou, 313000
ChinaSite Not Available
Center Hospital of Jinan
Jinan, 250013
ChinaSite Not Available
Jincheng General Hospital
Jincheng, 048000
ChinaSite Not Available
Lishui Municipal Central Hospital
Lishui, 323020
ChinaSite Not Available
Luoyang Third People's Hospital
Luoyang, 471002
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000
ChinaSite Not Available
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
ChinaSite Not Available
Affiliated Hospital of Nantong University
Nantong, 226001
ChinaSite Not Available
The First Affiliated Hospital of Ningbo University
Ningbo, 315010
ChinaSite Not Available
Panjin Liao Oil Gem Flower Hospital
Panjin, 124000
ChinaSite Not Available
Pingxiang People's Hospital
Pingxiang, 337000
ChinaSite Not Available
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, 200240
ChinaSite Not Available
Siping Central People's Hospital
Siping, 136000
ChinaSite Not Available
Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, 300070
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 30052
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Medical University
Xi'an, 710077
ChinaSite Not Available
The People's Hospital Of Xuancheng City
Xuancheng, 242000
ChinaSite Not Available
Yichang NO.1 People's Hospital
Yichang, 443000
ChinaSite Not Available
General Hospital of Ningxia Medical University
Yinchuan, 750004
ChinaSite Not Available
Yueyang People's Hospital
Yueyang, 414109
ChinaSite Not Available
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