A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
- Registration Number
- NCT06066515
- 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 30 kg/m² or more, or
* a BMI of 27 kg/m² or more and at least one health problem related to their weight.
People with type 2 diabetes cannot 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 overweight or obesity 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
- 727
-
Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
-
Body mass index (BMI) ≥30 kg/m^2 at screening, OR BMI ≥27 kg/m^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
- Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (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
- Others.
-
History of at least one self-reported unsuccessful dietary effort to lose body weight.
Further inclusion criteria apply.
- Body weight change (self-reported) of >5% within 3 months before screening.
- Treatment with any medication for the indication obesity within 3 months before screening.
- Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.
- Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
- Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
- History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Further exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Survodutide 3.6 mg survodutide - Placebo Placebo - Survodutide 6.0 mg survodutide -
- Primary Outcome Measures
Name Time Method Percentage change in body weight from baseline to Week 76 Baseline and at Week 76 Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76 Baseline and at Week 76
- Secondary Outcome Measures
Name Time Method Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76 Baseline and at Week 76 Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76 Baseline and at Week 76 Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76 Baseline and at Week 76 Absolute change from baseline to Week 76 in body weight (kg) Baseline and Week 76 Absolute change from baseline to Week 76 in waist circumference (cm) Baseline and at Week 76 Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg) Baseline and at Week 76 Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO) Baseline and at Week 76 "Capacity to Resist" domain score of the Eating Behaviour PRO 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 Baseline and at Week 76 Eating Behaviour PRO total 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 body mass index (BMI) (kg/m2) Baseline and at Week 76 Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg) Baseline and at Week 76 Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%) Baseline and at Week 76 Absolute change from baseline to Week 76 in HbA1c (mmol/mol) Baseline and at Week 76 Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L) Baseline and at Week 76 Absolute change from baseline to Week 76 in total cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in triglycerides (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in free fatty acids (mg/dL) Baseline and at Week 76 Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L) Baseline and at Week 76 Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L) Baseline and at Week 76 Absolute change from baseline to Week 76 in total fat volume (L) Baseline and at Week 76 Absolute change from baseline to Week 76 in lean body volume (L) Baseline and at Week 76 Absolute change from baseline to Week 76 in visceral fat volume (L) Baseline and at Week 76 Absolute change from baseline to Week 76 in subcutaneous fat volume (L) Baseline and at Week 76. Relative change from baseline to Week 76 in total fat volume (%) Baseline and at Week 76 Relative change from baseline to Week 76 in lean body volume (%) Baseline and at Week 76 Relative change from baseline to Week 76 in visceral fat volume (%) Baseline and at Week 76 Relative change from baseline to Week 76 in subcutaneous fat volume (%) Baseline and at Week 76. Relative change from baseline to Week 76 in liver fat content (%) Baseline and at Week 76
Trial Locations
- Locations (118)
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Evanston Premier Healthcare Research LLC
🇺🇸Skokie, Illinois, United States
Velocity Clinical Research-Valparaiso-68883
🇺🇸Valparaiso, Indiana, United States
Velocity Clinical Research-Sioux City-69728
🇺🇸Sioux City, Iowa, United States
AMR Lexington
🇺🇸Lexington, Kentucky, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
StudyMetrix Research, LLC
🇺🇸Saint Peters, Missouri, United States
Premier Research, Inc.
🇺🇸Trenton, New Jersey, United States
Accellacare-Wilmington-67123
🇺🇸Wilmington, North Carolina, United States
Valley Weight Loss Clinic
🇺🇸Fargo, North Dakota, United States
Trial Management Associates
🇺🇸Myrtle Beach, South Carolina, United States
Velocity Clinical Research, Vestal
🇺🇸Vestal, New York, United States
Southgate Medical Group/ Southgate Medical Park
🇺🇸West Seneca, New York, United States
Texas Diabetes and Endocrinology
🇺🇸Austin, Texas, United States
Juno Research, LLC
🇺🇸Houston, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
CORE Research Group
🇦🇺Milton, Queensland, Australia
Griffith Health
🇦🇺Southport, Queensland, Australia
Monash University
🇦🇺Box Hill, Victoria, Australia
Beijing Pinggu Hospital
🇨🇳Beijing, China
Huzhou Central Hospital
🇨🇳Huzhou, China
New Horizon Research Center-Miami-69732
🇺🇸Miami, Florida, United States
West Orange Endocrinology
🇺🇸Ocoee, Florida, United States
East-West Medical Research
🇺🇸Honolulu, Hawaii, United States
EmVenio Research-Phoenix-69743
🇺🇸Phoenix, Arizona, United States
Encompass Clinical Research, Spring Valley
🇺🇸Spring Valley, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Alliance for Multispecialty Research-Coral Gables-68872
🇺🇸Coral Gables, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
East Coast Institute for Research, LLC-Jacksonville-55146
🇺🇸Jacksonville, Florida, United States
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
EmVenio Research-Oklahoma City-70053
🇺🇸Oklahoma City, Oklahoma, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Hunter Diabetes Centre
🇦🇺Merewether, New South Wales, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Baker Heart and Diabetes Institute
🇦🇺Melbourne, Victoria, Australia
Keogh Institute for Medical Research
🇦🇺Nedlands, Western Australia, Australia
ASZ - Campus Aalst
🇧🇪Aalst, Belgium
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Roeselare - HOSP AZ Delta
🇧🇪Roeselare, Belgium
Dr. James Lai
🇨🇦Vancouver, British Columbia, Canada
Aggarwal and Associates Ltd.
🇨🇦Brampton, Ontario, Canada
The Wharton Medical Clinic Clinical Trials Inc.
🇨🇦Hamilton, Ontario, Canada
Milestone Research Inc.
🇨🇦London, Ontario, Canada
James Cha, MD
🇨🇦Oshawa, Ontario, Canada
Stouffville Medical Centre
🇨🇦Stouffville, Ontario, Canada
Albion Finch Medical Centre
🇨🇦Toronto, Ontario, Canada
Sameh Fikry Medicine Professional Corporation
🇨🇦Waterloo, Ontario, Canada
Power Clinical Research
🇨🇦Montreal, Quebec, Canada
ViaCar Recherches Cliniques Inc. (Greenfield Park)
🇨🇦Greenfield Park, Quebec, Canada
Peking University People's Hospital
🇨🇳Beijing, China
Changzhou Second People's Hospital
🇨🇳Changzhou, China
The First Hospital of Jilin University
🇨🇳Changchun, China
Forth Clinical Hospital of Harbin Medical University
🇨🇳Harbin, China
Center Hospital of Jinan
🇨🇳Jinan, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
MVZ im Altstadt-Caree Fulda GmbH
🇩🇪Fulda, Germany
Diabetes Zentrum Hamburg West
🇩🇪Hamburg, Germany
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, China
Pingxiang People's Hospital
🇨🇳Pingxiang, China
Shanghai Municipal Hospital of Traditional Chinese Medicine
🇨🇳Shanghai, China
Shanghai Fifth People's Hospital affiliated to Fudan University
🇨🇳Shanghai, China
Siping Central People's Hospital
🇨🇳Siping, China
Suzhou Municipal Hospital
🇨🇳Suzhou, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, China
HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki
🇫🇮Helsinki, Finland
StudyCor Oy
🇫🇮Jyväskylä, Finland
Itä-Suomen yliopisto/Health Step Finland Oy
🇫🇮Kuopio, Finland
CRST - Clinical Research Services Turku
🇫🇮Turku, Finland
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Institut für Diabetesforschung Münster GmbH
🇩🇪Münster, Germany
Fukuhama Chuo Clinic
🇯🇵Fukuoka, Fukuoka, Japan
Kobe University Hospital
🇯🇵Hyogo, Kobe, Japan
Noritake Clinic
🇯🇵Ibaraki, Ushiku, Japan
Soka Sugiura Naika Clinic
🇯🇵Saitama, Soka, Japan
Hachioji Diabetes Clinic
🇯🇵Tokyo, Hachioji, Japan
The Catholic University of Korea, Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Kyungpook National Univ. Hosp
🇰🇷Daegu, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
PT & R
🇳🇱Born, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
P3 Research Dunedin
🇳🇿Dunedin, New Zealand
Southern Clinical Trials Tasman
🇳🇿Nelson, New Zealand
P3 Research-Newtown Wellington NZ-33770
🇳🇿Newtown Wellington NZ, New Zealand
Optimal Clinical Trials North
🇳🇿Rosedale, Auckland, New Zealand
P3 Research-Tauranga-34833
🇳🇿Tauranga, New Zealand
PI HOUSE Sp. z o.o., Gdansk
🇵🇱Gdansk, Poland
ETG Lublin
🇵🇱Lublin, Poland
Velocity Nova Sp z o.o.
🇵🇱Pulawy, Poland
ETG Siedlce
🇵🇱Siedlce, Poland
Clinical Research Center METABOLICA lek. Robert Witek
🇵🇱Tarnow, Poland
Ladulaas Kliniska Studier
🇸🇪Borås, Sweden
Forskningsenheten Carlanderska
🇸🇪Göteborg, Sweden
Sabbatsbergs sjukhus
🇸🇪Stockholm, Sweden
Medicinmottagning 5/Överviktsenheten
🇸🇪Örebro, Sweden
Waterloo Medical Centre
🇬🇧Blackpool, United Kingdom
Bradford on Avon Health Centre
🇬🇧Bradford on Avon, United Kingdom
Burbage Surgery
🇬🇧Burbage, Hinkley, United Kingdom
Kiltearn Medical Centre
🇬🇧Nantwich, United Kingdom
Clifton Medical Centre, Rotherham
🇬🇧Rotherham, United Kingdom
Trowbridge Health Centre
🇬🇧Trowbridge, United Kingdom