A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
This research study is about a new medicine called Enicepatide. It's for adults aged 18 to 75 who have both type 2 diabetes and are overweight or obese. The main goals are to find out how well Enicepatide works to help control blood sugar and manage weight, and to check if it's safe. Participants will be randomly given either Enicepatide at different doses or a placebo (a dummy medicine with no active ingredients). This is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over. This helps ensure the results are accurate and unbiased.
At a glance
What is this study about?
This research study is looking into a new medicine called Enicepatide, and it's specifically for people who are overweight or obese and also have type 2 diabetes. We know that managing both weight and blood sugar can be challenging, and this study aims to see if Enicepatide could be a helpful new option.
Type 2 diabetes is a common condition where your body doesn't use insulin properly, leading to high blood sugar levels. Being overweight or obese can make it harder to control type 2 diabetes. The researchers want to find the best dose of Enicepatide that is both effective and safe for people like you.
Many studies like this are needed before a new medicine can become widely available. Your participation could help us learn more about how to better support people living with type 2 diabetes and excess weight in the future.
Key takeaways
- This study is for adults with type 2 diabetes who are also overweight or obese.
- It tests a new medicine called Enicepatide against a placebo (dummy medicine).
- The goal is to find out if Enicepatide is safe and effective for blood sugar and weight.
- You would have regular check-ups and follow specific instructions.
- Participation involves some risks, but also potential benefits like close medical care.
Who may be eligible?
To join this study, you generally need to be between 18 and 75 years old and have been diagnosed with type 2 diabetes. You also need to be overweight or obese (this is measured by something called your Body Mass Index, or BMI). Your blood sugar control, measured by a test called HbA1c, needs to be within a specific range.
It's important that you've tried to lose weight through diet and exercise before, but haven't been successful. You might be managing your diabetes with diet and exercise alone, or taking metformin or a specific type of medication called an SGLT-2 inhibitor.
There are also some reasons why you might not be able to join. For instance, if you have type 1 diabetes, or have had severe low blood sugar episodes recently. Certain eye problems related to diabetes, specific nerve issues, or taking particular medications for weight loss or diabetes could also mean you're not suitable for this 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 75 years old?
- Do you have type 2 diabetes?
- Are you considered overweight or obese (BMI of 25 or more)?
- Have you tried to lose weight with diet and exercise before, but not succeeded?
- Are you currently managing your diabetes with diet/exercise, metformin, or an SGLT-2 inhibitor?
- Have you *not* had severe low blood sugar recently, or type 1 diabetes?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive the new medicine, Enicepatide, at a low, medium, or high dose, or a placebo (which looks like the medicine but contains no active ingredients). Neither you nor your study doctor will know which one you are getting. You'll have regular visits to the study clinic where the research team will check your health, take blood and urine samples, and monitor your blood sugar levels and weight. They will also ask you questions about how you feel and if you're experiencing any side effects. You'll receive the study medication and instructions on how to use it. The total duration of your participation in the study will involve regular follow-up visits over a period that will be explained to you in detail.
Potential risks and benefits
Locations (70)
- Central Alabama ResearchVerified postcodeBirmingham, United States
- University of Alabama at Birmingham (UAB)Verified postcodeBirmingham, United States
- Lakeview Clinical Research, LLCVerified postcodeGuntersville, United States
- Yuma Clinical TrialsVerified postcodeYuma, United States
- AMCR InstituteVerified postcodeEscondido, United States
- Ark Clinical-Fountain ValleyVerified postcodeFountain Valley, United States
- Orange Country Research CenterVerified postcodeLake Forest, United States
- Ark Clinical ResearchVerified postcodeLong Beach, United States
- Catalina Research Institute, LLCVerified postcodeMontclair, United States
- Asclepes Research CentersVerified postcodeSherman Oaks, United States
- Encompass Clinical ResearchVerified postcodeSpring Valley, United States
- Flourish Research - Boca RatonVerified postcodeBoca Raton, United States
Common questions
What is Enicepatide?
Enicepatide is a new medicine being tested to see if it can help people with type 2 diabetes who are also overweight or obese.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real treatment but contains no active drug. It helps researchers compare the real medicine's effects accurately.
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 doctors will know if you're getting Enicepatide or the placebo until the study is over.
How long will I need to be in the study?
The full duration of the study, including all visits and follow-ups, will be explained in detail by the study team.
What if I change my mind about participating?
You are free to leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.