临床试验/NCT06176365

NCT06176365

已完成

3 期

A Phase III, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of Survodutide Administered Subcutaneously Compared With Placebo in Patients With Obesity Disease in Japanese

Boehringer Ingelheim55 个研究点分布在 1 个国家目标入组 274 人2024年1月16日

适应症Obesity

干预措施Placebo matching survodutide Survodutide

概览

阶段: 3 期
干预措施: Placebo matching survodutide
疾病 / 适应症: Obesity
发起方: Boehringer Ingelheim
入组人数: 274
试验地点: 55
主要终点: Percentage change in body weight from baseline to Week 76
状态: 已完成
最后更新: 前天

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is open to adults who are at least 18 years old and have

a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or
a BMI of 27 kg/m² or more and at least two health problems related to their weight.

People who have either type 2 diabetes, high blood pressure, or increased blood lipids can 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 obesity disease 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.

注册库

clinicaltrials.gov

开始日期

2024年1月16日

结束日期

2025年12月3日

最后更新

前天

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Boehringer Ingelheim

责任方

Sponsor

入排标准

入选标准

•Male or female, age ≥18 years at the time of signing informed consent
•Body Mass Index (BMI)
•≥35 kg/m² at screening with the presence of at least one obesity-related comorbidities (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline OR
•BMI ≥27 kg/m² at screening with the presence of at least two obesity-related comorbidities (treated or untreated) according to the JASSO guideline For all trial patients, at least one co-morbidity should be the following (i)-(iii).
•i. Type 2 diabetes mellitus (T2DM)
•Diagnosed with T2DM (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening
•HbA1c ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol) as 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, SGLT-2i, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 antihyperglycaemia medications (metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone) according to local label ii. Hypertension iii. Dyslipidaemia
•History of at least one self-reported unsuccessful dietary effort to lose body weight
•Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

排除标准

•Body weight change (self-reported) \>5% within 3 months before screening
•Treatment with any medication for the indication obesity within 3 months before screening
•Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the gastrointestinal (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.
•Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
•For trial patients without T2DM:
•History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening
•For trial patients with T2DM:
•History of T1DM
•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, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and DPP-4i)
•New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial

研究组 & 干预措施

Placebo group

干预措施: Placebo matching survodutide

Survodutide - 6.0 mg

干预措施: Survodutide

Survodutide - 3.6 mg

干预措施: Survodutide

结局指标

主要结局

Percentage change in body weight from baseline to Week 76

时间窗: at baseline, at week 76

Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

时间窗: at baseline, at week 76

次要结局

Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76(at baseline, at week 76)
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76(at baseline, at week 76)
Absolute change from baseline to Week 76 in body weight (kg)(at baseline, at week 76)
Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²)(at baseline, at week 76)
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76(at baseline, at week 76)
Absolute change from baseline to Week 76 in waist circumference measured at umbilical level (cm)(at baseline, at week 76)
Absolute change from baseline to Week 76 in waist circumference measured at midway between the lower rib margin and the iliac crest (cm)(at baseline, at week 76)
Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)(at baseline, at week 76)
Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)(at baseline, at week 76)
Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour Patient reported outcome (PRO)(at baseline, at week 76)
Absolute change from baseline to Week 76 in Eating Behaviour PRO total score(at baseline, at week 76)
Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)(at baseline, at week 76)
Absolute change from baseline to Week 76 in HbA1c (mmol/mol)(at baseline, at week 76)
Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)(at baseline, at week 76)
Absolute change from baseline to Week 76 in total cholesterol (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in high density lipoprotein (HDL) (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in low density lipoprotein (LDL) (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in triglycerides (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in free fatty acids (mg/dL)(at baseline, at week 76)
Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)(at baseline, at week 76)
Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)(at baseline, at week 76)
Relative change from baseline to Week 76 in liver fat content (%), assessed by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)(at baseline, at week 76)
Absolute change from baseline to Week 76 in total fat mass (percentage [%]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in total fat mass (volume [L]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in lean body mass (percentage [%]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in lean body mass (volume [L]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in visceral fat mass (percentage [%]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in visceral fat mass (volume [L]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in contractile thigh muscle volume (percentage [%]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in contractile thigh muscle volume (volume [L]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in sub-cutaneous fat volume (volume [L]) assessed by MRI for body composition(at baseline, at week 76)
Absolute change from baseline to Week 76 in sub-cutaneous fat volume (percentage [%]) assessed by MRI for body composition(at baseline, at week 76)