A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
This research study is testing a new medicine called RO7204239. It's being combined with an existing treatment, tirzepatide, to see if it can help adults lose weight. We're looking for people who are overweight or have obesity and at least one related health issue, but who do not have diabetes. The main goal is to find out if this combination leads to more weight loss after 48 weeks compared to tirzepatide alone, and if it's safe and well-tolerated. It's a key step to understanding how this new medicine might help people manage their weight and improve their health.
At a glance
What is this study about?
This study is exploring a new way to help people manage their weight. It's looking at a medicine called RO7204239, which is quite new, and combining it with another medicine called tirzepatide, which is already used to help with weight management. The main idea is to see if taking these two medicines together can help people lose weight more effectively than taking tirzepatide alone.
The study focuses on adults who are overweight or have obesity and also have at least one other health condition linked to their weight, such as high blood pressure or sleep apnoea. It's important to note that this study is not for people who have diabetes. The aim is to carefully compare the effects of the new combination treatment against a 'dummy' treatment (placebo) alongside tirzepatide, to understand if RO7204239 makes a real difference.
Finding new and effective ways to help people living with obesity and overweight conditions is very important, as these conditions can lead to various health problems. This research will help doctors and researchers learn more about how RO7204239 works and if it could be a useful treatment option in the future. It's currently in an earlier stage of testing, known as Phase 2, which focuses on safety and finding the best dose.
Key takeaways
- Tests a new medicine (RO7204239) combined with an existing one (tirzepatide) for weight loss.
- For adults who are overweight or have obesity and related health issues, but NOT diabetes.
- Compares the new combination to tirzepatide plus a dummy medicine.
- Involves regular clinic visits over approximately 100 weeks.
- Aims to check safety and how well the treatment helps with weight loss.
Who may be eligible?
To join this study, you generally need to be an adult (18 years or older) and either have a Body Mass Index (BMI) of 30 or higher, or have a BMI between 27 and 30 with at least one weight-related health issue like high blood pressure, high cholesterol, or sleep apnea. You should have tried to lose weight with diet and exercise before, but without lasting success. Also, your weight should have been fairly stable, meaning it hasn't changed by more than 5 kilograms (about 11 pounds) in the last three months.
However, there are reasons why you might not be able to join. For example, if you have diabetes, or if you've had surgery for weight loss in the past. People with certain serious heart conditions in the last six months, or those with significant untreated health problems like kidney, liver, or active cancer, would also not be able to take part. The study also excludes people who have done extreme diets recently.
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 18 years old or older?
- Do you have a BMI of 30 or higher, OR a BMI between 27 and 30 with a weight-related health problem (like high blood pressure or sleep apnea)?
- Have you tried to lose weight before with diet and exercise, but it hasn't worked long-term?
- Have you NOT been diagnosed with diabetes?
- Have you NOT had weight-loss surgery or certain serious heart problems recently?
What does participation involve?
If you join this study, your journey will be split into a few stages. First, there's a 4-week 'screening' period to check if you're a good fit. After that, you'll enter the main 'treatment' period, which lasts 48 weeks. During this time, everyone will receive tirzepatide, and you'll also be randomly assigned to receive either RO7204239 or a placebo (a dummy medicine that looks like RO7204239). Neither you nor your study doctor will know which one you are receiving.
Following the main treatment, there's a 24-week 'extension' period where you'll stop taking tirzepatide, and then a further 24-week 'follow-up' period after all treatment has stopped. Throughout this time, you'll have regular visits to the clinic for check-ups, blood tests, and to discuss how you're feeling. This allows the study team to monitor your health, how the medicines are affecting you, and track any changes in your weight and other health markers. The total duration of your participation, including follow-up, will be around 100 weeks.
Potential risks and benefits
Locations (35)
- Pinnacle Research GroupVerified postcodeAnniston, United States
- Encompass Clinical ResearchVerified postcodeSpring Valley, United States
- K2 Medical Research-Winter GardenVerified postcodeClermont, United States
- Rophe Adult and Pediatric Medicine/SKYCRNGVerified postcodeUnion City, United States
- Accellacare of Duly Health and CareVerified postcodeOak Lawn, United States
- Rochester Clinical ResearchVerified postcodeRochester, United States
- Accellacare of SalisburyVerified postcodeSalisbury, United States
- Accellacare of Piedmont HealthcareVerified postcodeStatesville, United States
- Accellacare of Wilmington, LLCVerified postcodeWilmington, United States
- Accellacare Research of Winston SalemVerified postcodeWinston-Salem, United States
- NexGen ResearchVerified postcodeLima, United States
- Accellacare of Bristol/ Internal Medicine & PediatricsVerified postcodeBristol, United States
Common questions
What is RO7204239?
RO7204239 is a new medicine being tested in this study to see if it can help adults with obesity or overweight manage their weight.
What is tirzepatide?
Tirzepatide is a medicine that is already available and used to help people with weight management, and it will be part of the background treatment for everyone in this study.
Can I join if I have diabetes?
No, this particular study is not for people who have diabetes. Participants must not have a history or diagnosis of diabetes.
Will I know if I'm getting the new medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving RO7204239 or the placebo alongside tirzepatide.
How long will I be in the study?
If you join, the study will involve a total of around 100 weeks, including initial checks, treatment periods, and follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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