RecruitingPHASE3INTERVENTIONAL

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

This research study is testing a new medicine called enicepatide. It's for people who are overweight or have obesity and also have type 2 diabetes. The main goal is to find out if enicepatide can help people lose weight effectively and safely. Participants will either receive enicepatide or a dummy medicine (placebo). Scientists want to see how different amounts of the medicine work compared to not taking the medicine at all. If you have type 2 diabetes and are struggling with your weight, this study might be looking for people like you to help understand this new treatment better.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,600

Start

23 Mar 2026

Estimated completion

07 Aug 2028

Obesity or Overweight Type 2 Diabetes Mellitus

What is this study about?

This study is about a new medicine called enicepatide. It's designed for people who are carrying too much weight, either being overweight or having obesity, and who also have a condition called type 2 diabetes. Living with both of these can be challenging, and researchers are always looking for new ways to help manage them effectively.

The main aim of this study is to see if enicepatide can help people lose weight, and just as importantly, if it is safe to use. Some participants will receive the active medicine, while others will get a 'placebo' – a dummy medicine that looks the same but contains no active ingredients. This helps researchers compare the effects of the active medicine fairly. The information gathered will help us understand if enicepatide could be a new option for people managing these conditions.

Type 2 diabetes is a common condition where your body struggles to use sugar (glucose) for energy properly, which can lead to high blood sugar levels. Carrying extra weight can make type 2 diabetes harder to manage. This study hopes to find out if enicepatide can be a helpful new tool in managing both weight and blood sugar for people with type 2 diabetes. We are committed to making sure any new treatments are both effective and safe for patients.

Key takeaways

This study is testing a new medicine called enicepatide.
It's for people who are overweight/have obesity AND type 2 diabetes.
The aim is to see if it helps with weight loss and is safe.
You might receive the new medicine or a dummy medicine (placebo).
Participation involves regular clinic visits and health checks.
You can stop taking part at any time.

Who may be eligible?

To join this study, you need to be able to give yourself the study medicine or have someone trained help you if you can't see well or have physical challenges. You must have been diagnosed with type 2 diabetes, with your blood sugar control (HbA1c) being between 6.5% and 10%. If you're taking medicine for your diabetes, it needs to have been stable for at least 3 months, and you can't be taking certain types of diabetes medicines, like DPP-4 inhibitors or GLP-1 RAs.

You also need to be overweight or have obesity, specifically your Body Mass Index (BMI) should be 27 or higher. You should have tried to lose weight before through diet and exercise, but it hasn't worked as well as you hoped. The study is open to both men and women aged 18 or older.

However, you can't join if you have type 1 diabetes, have had severe blood sugar lows recently, or have very high blood sugar levels regularly. You also can't take part if your weight has changed a lot recently (more than 5 kg in 3 months) for other reasons, if you have certain other hormone-related causes for your obesity, or if you've had weight-loss surgery (unless it was liposuction or a tummy tuck more than a year ago). Certain heart conditions, stomach problems, or poorly controlled high blood pressure in the last three months would also mean you couldn't take part.

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.

Do you have type 2 diabetes?
Is your HbA1c (blood sugar control) between 6.5% and 10%?
Is your BMI (Body Mass Index) 27 or higher?
Have you tried to lose weight with diet and exercise before, but it didn't work well enough?
Are you 18 years old or older?
Have you had recent heart problems (within 3 months)? (If yes, you might not be able to join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have several visits to the clinic for health checks and tests. You'll be given the study medicine (either enicepatide or a placebo) to take regularly, and you'll learn how to inject it yourself, or someone can help you. Your progress will be carefully monitored through blood tests, measurements, and regular check-ups. The study will last for a set period, and you'll have follow-up appointments even after you stop taking the medicine to make sure you're doing well. All details about the total duration and specific appointments will be explained to you before you agree to join.

Potential risks and benefits

Taking part in a study means you might benefit from a new treatment before it's widely available, and you'll receive careful medical attention throughout. However, there's no guarantee the new medicine will work for you, and like all medicines, enicepatide could have side effects. These will be fully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (122)

Lakeview Clinical Research
Verified postcode
Guntersville, United States· Recruiting
Arizona Clinical Trials
Verified postcode
Tucson, United States· Recruiting
Orange County Research Center
Verified postcode
Lake Forest, United States· Recruiting
Ark Clinical Research
Verified postcode
Long Beach, United States· Recruiting
Catalina Research Institute, LLC
Verified postcode
Montclair, United States· Recruiting
Infinity Clinical Research
Verified postcode
Norco, United States· Recruiting
Prospective Research Innovations Inc.
Verified postcode
Rancho Cucamonga, United States· Recruiting
Encompass Clinical Research
Verified postcode
Spring Valley, United States· Recruiting
Emerson Clinical Research Institute
Verified postcode
Washington D.C., United States· Recruiting
Tampa Bay Medical Research, Inc.
Verified postcode
Clearwater, United States· Recruiting
Center for Diabetes, Obesity and Metabolism Inc
Verified postcode
Pembroke Pines, United States· Recruiting
Progressive Medical Research
Verified postcode
Port Orange, United States· Recruiting

Common questions

What is type 2 diabetes?

Type 2 diabetes is a condition where your body doesn't use sugar (glucose) properly for energy, leading to high blood sugar levels.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It helps researchers compare the effects of the new medicine fairly.

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

No, during the study, neither you nor the study team will know whether you are receiving the active medicine or the placebo. This is to ensure fair and accurate results.

How long will I need to be in the study?

The total length of time you'd be involved in the study will be fully explained to you before you decide to join. It includes taking the medicine and follow-up checks.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only) Official trial record

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