A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight
This study aims to find out if a new medicine, BI 3034701, can help adults aged 18-74 who are living with obesity or overweight to lose weight. You could be eligible if your BMI is 30 or more, or 27 or more with a weight-related health issue, and you haven't succeeded with diet changes before. People with type 2 diabetes cannot join. Most participants will receive the study medicine through injections under the skin twice a week for 42 weeks, along with healthy eating and exercise advice. Some will receive a dummy medicine for comparison. Over 10 months, you'll have regular check-ups to monitor weight, health, and any effects.
At a glance
What is this study about?
This study, called "A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight," is looking into a new medicine. It's called BI 3034701, and researchers want to see if it can help adults who are living with obesity or are overweight to lose weight.
Being overweight or living with obesity can sometimes lead to other health problems. Medicines like BI 3034701 are being developed to offer another option for weight management, alongside changes to diet and exercise. This study is in an early stage (Phase 2), meaning it's a key step in understanding how well the medicine works and if it's safe.
The main goal is to compare how people who take BI 3034701 lose weight compared to those who receive a dummy medicine called a placebo. All participants will also get advice on healthy eating and regular exercise, which are important parts of managing weight.
Key takeaways
- Testing a new medicine (BI 3034701) for weight loss.
- For adults aged 18-74 with obesity or overweight.
- Combines medicine with diet and exercise advice.
- Involves injections twice weekly and regular clinic visits.
- Your health and weight will be closely monitored.
- Most participants will receive the active medicine.
Who may be eligible?
This study is for adults generally between 18 and 74 years old. To take part, your body mass index (BMI) typically needs to be 30 or higher. If your BMI is 27 or higher, you might also qualify if you have at least one health issue linked to your weight.
You should have tried to lose weight by changing your diet in the past but haven't been successful. It's important that you haven't had a big change (over 5%) in your body weight in the last three months before screening.
Unfortunately, you cannot join this study if you have type 2 diabetes. Also, women who could become pregnant must be willing and able to use reliable birth control during the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 74 years old?
- Is your BMI 30 or higher, or 27 or higher with a weight-related health problem?
- Have you tried to lose weight with diet changes before but it didn't work?
- Do you NOT have type 2 diabetes?
- Are you able to use reliable birth control if you could become pregnant?
- Are you willing to commit to regular clinic visits and follow study instructions?
What does participation involve?
If you decide to take part, you'll be in the study for about 10 months in total. During this time, you'll visit the study clinic about 15 times for check-ups and tests.
Most participants will receive the study medicine, BI 3034701, but some will get a dummy medicine (placebo). You'll inject this medicine under your skin twice a week for 42 weeks. Don't worry, you'll be taught how to do this or someone trained can help you. Everyone in the study will also receive advice on making healthy changes to their diet and exercising regularly.
Your weight will be measured regularly, and you'll have some blood tests. You'll also be asked to answer questions about how you're feeling and keep a diary of what you eat and how active you are. The study team will carefully monitor your health throughout and note any changes or unwanted effects.
Potential risks and benefits
Locations (57)
- Cahaba Research, Inc. - Trussville LocationVerified postcodeBirmingham, United States
- CMR of Greater New Haven, LLCVerified postcodeHamden, United States
- Optimus U Corporation-Miami-69452Verified postcodeMiami, United States
- Javara-Fayetteville-67354Verified postcodeFayetteville, United States
- Monroe Biomedical Research - LouisvilleVerified postcodeLouisville, United States
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States
- Arcturus Healthcare - Troy Internal Medicine Research DivisionVerified postcodeTroy, United States
- StudyMetrix Research, LLCVerified postcodeCity of Saint Peters, United States
- Clinvest Research LLCVerified postcodeSpringfield, United States
- Centricity Research - Morehead CityVerified postcodeMorehead City, United States
- Accellacare-Wilmington-67123Verified postcodeWilmington, United States
- Lillestol Research, LLCVerified postcodeFargo, United States
Common questions
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, you won't know specificially, but most participants have a high chance (more than 80%) of receiving the active medicine. This is a common way to test medicines fairly.
How will I take the study medicine?
The medicine or placebo will be given as injections under your skin, twice a week. You'll be shown exactly how to do this, or a trained person can help you.
How long will I be involved in the study?
You'll be part of the study for about 10 months, with 15 visits to the study clinic during that time.
What if I decide I don't want to continue?
You are free to leave the study at any time, for any reason. Your decision will not affect your routine medical care.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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