J1I-MC-GZQD: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7)
This research study, called TRIUMPH-7, is for adults who are overweight or have obesity and also experience chronic (long-lasting) lower back pain. It's investigating a new medicine called Retatrutide. Over 72 weeks, the study will compare Retatrutide to a placebo (a dummy medicine with no active ingredients). Researchers want to find out if Retatrutide can help reduce lower back pain and if it also helps with weight loss. This is an important step to see if this new treatment is safe and effective for these conditions. Participants will receive either the active drug or the placebo, and neither they nor their doctors will know which one they are getting until the study is over.
At a glance
What is this study about?
This study is called TRIUMPH-7, and it's looking into a new medicine called Retatrutide. We're interested in people who are living with two common health conditions: being overweight or having obesity, and also experiencing ongoing pain in their lower back. Many people find that these conditions can significantly affect their daily lives, and finding effective treatments is very important.
The main goal of this study is to see if Retatrutide can help reduce the amount of pain people feel in their lower back. We also want to understand if this medicine helps people to lose weight. To do this fairly, some participants will receive the active medicine, while others will receive a 'placebo', which looks exactly like the medicine but contains no active ingredients. This helps us to truly understand the effects of the new medicine.
This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might become widely available. We'll be carefully monitoring participants over 72 weeks to gather detailed information about how their pain changes and any changes in their body weight. The information we learn from this study will help us decide if Retatrutide could be a valuable new treatment option for people with these conditions in the future.
Key takeaways
- Targets adults with overweight/obesity and chronic low back pain.
- Investigates a new medicine called Retatrutide.
- Compares Retatrutide to a placebo (dummy medicine).
- Aims to see if it helps reduce back pain and aids weight loss.
- Participation lasts for around 72 weeks (about 1.5 years).
- It's a 'Phase 3' study, close to potential wider availability.
Who may be eligible?
This study is looking for adults aged 18 years and older. Both men and women are welcome to take part.
To be eligible, you must be either overweight or have obesity, and also be experiencing chronic low back pain. 'Chronic' means your back pain has been ongoing for a certain period of time, not just a recent injury.
There will be other health requirements and possibly some medications you might be taking that could mean you're not suitable for this study. These details will be checked carefully by the study team.
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 classify as overweight or living with obesity?
- Do you suffer from ongoing (chronic) lower back pain?
- Are you able to attend regular clinic visits for about 1.5 years?
- Are you comfortable potentially receiving a placebo instead of active medication?
What does participation involve?
If you decide to take part in this study, you would be involved for up to 72 weeks, which is about a year and a half. Throughout this time, you would have regular visits to the study clinic. During these visits, the study team would give you the medication (either Retatrutide or a placebo) and conduct various assessments.
These assessments would likely include checking your pain levels using a scale, measuring your body weight, and having blood tests to monitor your health. You might also fill out questionnaires about how you're feeling and how your pain is affecting you. It's important to attend all scheduled visits so the researchers can gather all the necessary information. At the end of the 72 weeks, there will be a final follow-up to ensure your well-being.
Potential risks and benefits
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Common questions
What is Retatrutide?
Retatrutide is a new medicine being studied to see if it can help with weight management and pain, specifically for people with chronic lower back pain who are also overweight or have obesity.
What does 'placebo-controlled' mean?
It means some people will get the active medicine (Retatrutide) and others will get a 'dummy' medicine (placebo) that looks the same but contains no active ingredients. This helps researchers fairly compare the effects.
How long will the study last?
If you take part, your involvement in the study will be for up to 72 weeks, which is about one and a half years.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving Retatrutide or the placebo until the study is finished.
What kind of pain is this study looking at?
The study focuses on 'chronic low back pain', which means pain in the lower part of your back that has been ongoing for a longer period of time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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