A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD
This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet.
The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight.
Participants are divided into 3 groups of almost equal size. 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 the skin once a week. All participants also receive counselling on diet and physical activity.
Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
Inclusion Criteria:
Further inclusion criteria apply.
Exclusion criteria:
Further exclusion criteria apply.
Colorado Springs, Colorado 80907, United States
Saint Augustine, Florida 32086, United States
Arlington Heights, Illinois 60005, United States
Winston-Salem, North Carolina 27104, United States
CABA, C1060ABN, Argentina
CABA, C1128AAF, Argentina
Ciudad Autonoma Buenos Aires, C1425AGC, Argentina
Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
Ciudad Autonoma de Bs As, C1120AAC, Argentina
Ciudad Autonoma de Bs As, C1180AAX, Argentina
Ciudad Autonoma de Buenos Aire, 1405, Argentina
Ciudad Autonoma de Buenos Aire, 1602, Argentina
Parque Velez Sarsfield, X5016KEH, Argentina
São Paulo, 01221-020, Brazil
Ostrava-Poruba, 708 52, Czechia
Pohlheim, 35415, Germany
Haidari-Athens, 12462, Greece
P. Faliro, 17562, Greece
Maharashtra, 440012, India
Aichi, Nagoya, 451-8511, Japan
Aichi, Nagoya, 454-0933, Japan
Aichi, Nagoya, 455-8530, Japan
Aichi, Nagoya, 457-8511, Japan
Chiba, Matsudo, 271-0077, Japan
Fukuoka, Okawa, 831-0016, Japan
Fukushima, Koriyama, 963-8851, Japan
Ibaraki, Mito, 311-4153, Japan
Kanagawa, Kawasaki, 212-0024, Japan
Kanagawa, Sagamihara, 252-5188, Japan
Kanagawa, Yokohama, 234-0054, Japan
Kochi, Kochi, 780-0863, Japan
Miyagi, Sendai, 980-0011, Japan
Okinawa, Urasoe, 901-2102, Japan
Osaka, Osaka, 543-8922, Japan
Saitama, Kawaguchi, 332-8558, Japan
Saitama, Koshigaya, 343-8577, Japan
Saitama, Sayama, 350-1305, Japan
Saitama, Sayama, 350-1305, Japan
Shiga, Omihachiman, 523-0082, Japan
Tokyo, Hachioji, 192-0918, Japan
Wakayama, Wakayama, 640-8158, Japan
Culiacán, 80230, Mexico
Lørenskog, 1478, Norway
Ponte de Lima, 4990-029, Portugal
Chia-Yi City, 40705, Taiwan
Taoyuan County, 333, Taiwan