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RecruitingPHASE3INTERVENTIONAL

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

This clinical trial is looking into a new medicine called enicepatide. It's for adults who are overweight or have obesity and have other health conditions linked to their weight, but importantly, they don't have type 2 diabetes. The main goal is to find out if enicepatide can help people lose weight effectively and safely. Participants in the study will either receive enicepatide or a placebo (a dummy medicine) to compare their effects. This is a Phase 3 study, meaning it's one of the final stages of testing before a medicine might become widely available. Researchers are keen to see if this new approach can offer a safe and helpful option for weight management.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
2,000
Start
16 Mar 2026
Estimated completion
28 Aug 2028

What is this study about?

This study is testing a new medicine called enicepatide, which is designed to help people manage their weight. It's for adults who are either overweight or have obesity and also have at least one other health issue related to their weight, such as prediabetes, high blood pressure, or sleep apnoea. An important point is that this study is specifically for people who do not have type 2 diabetes.

The medicine works by mimicking natural substances in your body that help control appetite and how your body uses energy. By gently adjusting these processes, researchers hope enicepatide can support healthy weight loss. The study is comparing different doses of enicepatide against a placebo, which looks exactly like the medicine but contains no active ingredients. This helps researchers understand if any changes are truly due to the medicine or other factors.

Finding new ways to manage weight is really important because carrying too much weight can lead to various health problems. If this medicine proves to be safe and effective, it could offer a valuable new treatment option for many people and help improve their overall health and well-being. This study is a key step in understanding its potential.

Key takeaways

  • This study tests a new weight management medicine called enicepatide.
  • It's for adults who are overweight or have obesity but do not have type 2 diabetes.
  • Participants will receive either enicepatide or a placebo.
  • The aim is to check if the medicine helps with weight loss and is safe.
  • Regular clinic visits and self-injections are part of taking part.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you generally need to be an adult (18 years or older) and meet certain criteria related to your weight. This means you would either have a Body Mass Index (BMI) of 30 or higher, which is generally considered obesity, or a BMI between 27 and 30, which is considered overweight, but with at least one other health condition linked to weight, like prediabetes or high blood pressure. You also need to have tried to lose weight through diet and exercise in the past without long-term success, and be able to give yourself injections or have someone help you.

There are also some reasons why you wouldn't be able to join. For example, if you have type 1 or type 2 diabetes, or if your obesity is caused by certain other rare medical conditions. You also can't have had major weight loss surgery in the past or be planning to have one. Conditions like recent heart problems, certain stomach issues, or poorly controlled high blood pressure would also mean you can't take part. The research team will carefully check all these details with you.

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.

  1. Are you 18 years old or older?
  2. Do you have obesity (BMI 30 or higher) OR are you overweight (BMI 27-29.9) with another weight-related health condition (like prediabetes or high blood pressure)?
  3. Have you tried to lose weight with diet and exercise before?
  4. Do you NOT have type 1 or type 2 diabetes?
  5. Have you NOT had weight-loss surgery in the past year, or have serious heart or stomach problems?
  6. Are you able to give yourself an injection or have someone help you?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to either receive the study medicine (enicepatide) or a placebo (a dummy medicine). You will be shown how to give yourself the medicine as an injection, or someone trained can help you if needed. Over the course of the study, you would attend regular visits to the clinic so the research team can monitor your health, check for any changes in your weight, and see how you are responding to the treatment. These visits will involve various assessments, which might include blood tests, physical exams, and discussions about how you're feeling. The total time you would be involved in the study would be explained by the research team, but studies like this often last for a year or more. You would also have check-ups after your main treatment period has finished.

Potential risks and benefits

Participating in a study like this might offer some benefits, such as receiving a potential new medicine for weight management and close medical monitoring throughout the trial. However, there's no guarantee the medicine will work for you, and you might receive the placebo. Potential risks could include side effects from the medicine, which will be carefully explained, or the usual discomforts associated with clinic visits and blood tests. Your safety is the top priority, and you'll be closely monitored for any problems. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (128)

  • Pinnacle Research Group
    Verified postcode
    Anniston, United States· Recruiting
  • Alabama Clinical Therapeutics
    Verified postcode
    Birmingham, United States· Recruiting
  • University of Alabama at Birmingham
    Verified postcode
    Birmingham, United States· Recruiting
  • Arizona Clinical Trials
    Verified postcode
    Tucson, United States· Recruiting
  • Artemis Institute for Clinical Research, LLC
    Verified postcode
    San Diego, United States· Recruiting
  • Yale University
    Verified postcode
    New Haven, United States· Recruiting
  • Rophe Adult and Pediatric Medicine/SKYCRNG
    Verified postcode
    Union City, United States· Recruiting
  • East-West Medical Research Institute
    Verified postcode
    Honolulu, United States· Recruiting
  • Elevate Clinical Research
    Verified postcode
    Gurnee, United States· Recruiting
  • Knownwell
    Verified postcode
    Schaumburg, United States· Recruiting
  • Monroe Biomedical Research
    Verified postcode
    Louisville, United States· Recruiting
  • Knownwell
    Verified postcode
    Needham, United States· Recruiting

Common questions

What is enicepatide?

Enicepatide is a new medicine being tested to help people manage their weight by affecting how hunger and fullness signals work in your body.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It's used for comparison to see if the real medicine has a true effect.

Can I join if I have type 2 diabetes?

No, this study is specifically for people who do not have type 2 diabetes.

How long will the study last?

The exact duration will be explained by the study team, but Phase 3 studies often involve participation for a year or more.

Will I know if I'm getting the actual medicine or the placebo?

No, participants usually do not know whether they are receiving the active medicine or the placebo. This helps ensure the study results are unbiased.

How to find out more

Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Study to Evaluate the Effects of Enicepatide (RO7…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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