A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
- Conditions
- Obesity
- Interventions
- Drug: Placebo matching survodutide
- Registration Number
- NCT06176365
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 274
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Survodutide - 3.6 mg Survodutide - Survodutide - 6.0 mg Survodutide - Placebo group Placebo matching survodutide -
- Primary Outcome Measures
Name Time Method Percentage change in body weight from baseline to Week 76 at baseline, at week 76 Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76 at baseline, at week 76
- Secondary Outcome Measures
Name Time Method Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76 at baseline, at week 76 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 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 The "Capacity to Resist domain score" of the Eating Behaviour Patient reported outcome (PRO) (units on a scale) will be derived as the sum of items in the domain (possible responses being 0="Not at all", 1="A little", 2="Moderately", 3="A lot", 4="Extremely").
The domain score is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.Absolute change from baseline to Week 76 in Eating Behaviour PRO total score at baseline, at week 76 The Eating Behaviour PRO total score (units on a scale) will be derived from the "Desire to Eat" and "Capacity to Resist" domain as the sum of all items (possible responses being 0="Not at all", 1="A little", 2="Moderately", 3="A lot", 4="Extremely").
Each domain consists of 6 items. The score is ranging between 0 and 48 and a higher score indicates a worse eating behaviour (greater desire to eat and/or lower capacity to resist).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 fasting plasma glucose (FPG) (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 alanine aminotransferase (ALT) (U/L) 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 HbA1c (mmol/mol) 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 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 skeletal muscle mass (volume [L]) assessed by MRI for body composition 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 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 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 skeletal muscle mass (percentage [%]) assessed by MRI for body composition at baseline, at week 76 Absolute change from baseline to Week 76 in sub-cutaneous fat mass (volume [L]) assessed by MRI for body composition at baseline, at week 76 Absolute change from baseline to Week 76 in sub-cutaneous fat mass (percentage [%]) assessed by MRI for body composition at baseline, at week 76
Related Research Topics
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Trial Locations
- Locations (28)
Shimamura Kinen Hospital
🇯🇵Tokyo, Nerima-ku, Japan
Chiba University Hospital
🇯🇵Chiba, Chiba, Japan
Hosokawa Surgery Clinic
🇯🇵Aichi, Nagoya, Japan
Gifu University Hospital
🇯🇵Gifu, Gifu, Japan
Yamasaki Family Clinic
🇯🇵Hyogo, Amagasaki, Japan
Motomachi Takatsuka Naika Clinic
🇯🇵Kanagawa, Yokohama, Japan
Kobe University Hospital
🇯🇵Hyogo, Kobe, Japan
Yoshimura Clinic
🇯🇵Kumamoto, Kumamoto, Japan
Medical Corporation KEISEIKAI Kajiyama Clinic
🇯🇵Kyoto, Kyoto, Japan
Suidoubashi Medical Clinic
🇯🇵Tokyo, Chiyoda-ku, Japan
Tokyo Center Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Tokyo Asbo Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Clinical Research Hospital Tokyo
🇯🇵Tokyo, Shinjuku-ku, Japan
HS Clinic
🇯🇵Tokyo, Shinjuku-ku, Japan
Shinei Medical Healthcare Clinic
🇯🇵Tokyo, Suginami-ku, Japan
ToCROM Clinic
🇯🇵Tokyo, Shinjyuku-ku, Japan
Ikebukuro Metropolitan Clinic
🇯🇵Tokyo, Toshima-ku, Japan
Jiyugaoka Yamada Clinic
🇯🇵Hokkaido, Obihiro, Japan
Morinagaueno Clinic
🇯🇵Kumamoto, Kumamoto, Japan
Ijinkai Takeda General Hospital
🇯🇵Kyoto, Kyoto, Japan
OCROM Clinic
🇯🇵Osaka, Suita, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Osaka, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Fukuwa Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Saino Clinic
🇯🇵Saitama, Tokorozawa, Japan
Dojinkinenkai Meiwa Hospital
🇯🇵Tokyo, Chiyoda-ku, Japan
New Medical Research System Clinic
🇯🇵Tokyo, Hachioji, Japan
Nagoya City University Hospital
🇯🇵Aichi, Nagoya, Japan