Official Title
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
Brief Summary

This study in China is open to adults who are at least 18 years old who are living withoverweight or obesity. People with a body mass index (BMI) of 28 kg/m^2 or higher or 24kg/m^2 or higher with at least 1 weight related problem can join the study. The mainpurpose of this study is to find out whether a medicine called survodutide helps peoplewith overweight or obesity. 2 different doses of survodutide are tested in this study.Participants are put into 3 groups by chance. Each participant has an equal chance ofbeing in each group. 2 groups get different doses of survodutide. 1 group gets placebo.Participants get survodutide or placebo as injections under the skin once a week forabout 19 months.Placebo injections look like survodutide injections but do not contain any medicine.Participants are in the study for about 21 months. During this time, there are 20 visits.14 visits are in person at the study site. Where possible, 6 visits can be done by videocall, or by phone in rare cases. During this time, doctors regularly measureparticipant's body weight. Results are compared between the survodutide groups andplacebo group to see whether the treatment works. The doctors also regularly checkparticipants' health and take note of any unwanted effects.

Detailed Description

Not Provided

Active, not recruiting
Obesity
Overweight

Drug: survodutide

once weekly subcutaneous injection
Other Name: BI 456906

Drug: Placebo matching BI 456906

Once weekly subcutaneous injection

Eligibility Criteria

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:

- Hypertension (defined as repeated, i.e. at least 3 measurements in resting
condition, systolic blood pressure (SBP) values of ≥140 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

- Cardiovascular disease (CVD) (e.g. heart failure (HF) with New York Heart
Association (NYHA) functional class II-III, history of ischaemic or
haemorrhagic stroke or cerebrovascular revascularisation procedure [e.g.
carotid endarterectomy and/or stent], myocardial infarction (MI), coronary
artery 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% (86
mmol/mol), and fasting plasma glucose (FPG) ≤11.1 mmol/L 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, 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

- Non-alcoholic steatohepatitis (NASH), as assessed in medical records by
histological liver assessment (within the last 6 months)

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Beijing Chao-Yang Hospital
Beijing, China

Peking University People's Hospital
Beijing, China

Beijing Pinggu Hospital
Beijing, China

The First Hospital of Jilin University
Changchun, China

The Second Hospital of Jilin University
Changchun, China

Changzhou Second People's Hospital
Changzhou, China

People's Hospital of Sichuan Province
Chengdu, China

Second Affiliated Hospital Chongqing Medical University
Chongqing, China

NanFang Hosptial
Guangzhou, China

Forth Clinical Hospital of Harbin Medical University
Harbin, China

Huzhou Central Hospital
Huzhou, China

Center Hospital of Jinan
Jinan, China

Jincheng General Hospital
Jincheng, China

Lishui Municipal Central Hospital
Lishui, China

The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China

Luoyang Third People's Hospital
Luoyang, China

The Second Affiliated Hospital of Nanjing Medical University
Nanjing, China

Affiliated Hospital of Nantong University
Nantong, China

The First Affiliated Hospital of Ningbo University
Ningbo, China

Panjin Liao Oil Gem Flower Hospital
Panjin, China

Pingxiang People's Hospital
Pingxiang, China

Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, China

Siping Central People's Hospital
Siping, China

Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, China

Tianjin Medical University General Hospital
Tianjin, China

Wuhan Union Hospital
Wuhan, China

The First Affiliated Hospital of Xi'an Medical University
Xi'an, China

The People's Hospital Of Xuancheng City
Xuancheng, China

Yichang NO.1 People's Hospital
Yichang, China

Yueyang People's Hospital
Yueyang, China

Not Provided

Boehringer Ingelheim
NCT Number
MeSH Terms
Obesity
Overweight