Clinical trial NCT06214741: A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study in China is open to adults who are at least 18 years old who are living with overweight or obesity. People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study. The main purpose of this study is to find out whether a medicine called survodutide helps people with 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 of being 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 for about 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 video call, or by phone in rare cases. During this time, doctors regularly measure participant's body weight. Results are compared between the survodutide groups and placebo group to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.


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.

Primary outcomes:
measure: Percentage change in body weight from baseline to Week 52
timeFrame: At baseline and at Week 52.
measure: Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
timeFrame: At baseline and at Week 52.
Secondary outcomes:
measure: Key secondary endpoint: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52
timeFrame: At baseline and at Week 52
measure: Key secondary endpoint: Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 52
timeFrame: At baseline and at Week 52
measure: Key secondary endpoint: Absolute change from baseline to Week 52 in waist circumference (cm)
timeFrame: At baseline and at Week 52
measure: Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in body weight (kg)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in glycosylated haemoglobin A1c (HbA1c) (%)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in HbA1c (mmol/mol)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in systolic blood pressure (SBP) (mmHg)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in diastolic blood pressure (DBP) (mmHg)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in body mass index (BMI) (kg/m^2)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in fasting plasma glucose (FPG) (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in fasting plasma insulin (FPI) (mIU/L)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in total cholesterol (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in high-density lipoprotein (HDL) cholesterol (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in low-density lipoprotein (LDL) cholesterol (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in very low-density lipoprotein (VDL) cholesterol (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in triglycerides (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in free fatty acids (mg/dL)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in alanine aminotransferase (ALT) (U/L)
timeFrame: At baseline and at Week 52
measure: Absolute change from baseline to Week 52 in aspartate aminotransferase (AST) (U/L)
timeFrame: At baseline and at Week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
city: Chengdu
country: China
facility: People's Hospital of Sichuan Province
city: Chongqing
country: China
facility: Second Affiliated Hospital Chongqing Medical University
city: Guangzhou
country: China
facility: NanFang Hosptial
city: Harbin
country: China
facility: Forth Clinical Hospital of Harbin Medical University
city: Huzhou
country: China
facility: Huzhou Central Hospital
city: Jinan
country: China
facility: Center Hospital of Jinan
city: Jincheng
country: China
facility: Jincheng General Hospital
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Panjin
country: China
facility: Panjin Liao Oil Gem Flower Hospital
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital affiliated to Fudan University
city: Siping
country: China
facility: Siping Central People's Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Chu Hisen-I Memorial Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
city: Xuancheng
country: China
facility: The People's Hospital Of Xuancheng City
city: Yichang
country: China
facility: Yichang NO.1 People's Hospital
city: Yueyang
country: China
facility: Yueyang People's Hospital
Study officials:
References: