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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

This research is an early study exploring a new weekly medicine called Retatrutide for people with type 2 diabetes. The main goal is to understand how taking Retatrutide once a week might affect blood sugar levels, especially focusing on how the body reacts if blood sugar drops too low, a condition called hypoglycemia. This is a very early phase of testing, sometimes called Phase 1, which helps scientists learn more about how a new medicine works in people and if it's generally safe. Participants will be adults aged 18 and over, and both men and women can join. The study doesn't aim to find a cure but rather to gather important information about this potential new treatment.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Eli Lilly & Co.
Enrolment target
78
Start
13 May 2025

What is this study about?

This study is looking into a new medicine called Retatrutide, which is given once a week, for people living with type 2 diabetes. Type 2 diabetes is a common condition where the body doesn't use insulin properly or doesn't make enough of it, leading to high blood sugar levels. Medicines like Retatrutide are being developed to help manage these sugar levels.

The main focus of this particular study is to understand what happens to a person's blood sugar if it gets too low after taking Retatrutide. When blood sugar drops too much, it's called hypoglycemia, and it can make you feel unwell. By carefully observing how people's bodies respond, researchers can learn important information about how safe and effective Retatrutide might be in managing blood sugar.

This is an early-stage study, meaning it's one of the first times this medicine is being tested in human volunteers. This helps researchers gather basic information about how the medicine works in the body and at what doses. The information collected from this study will help decide if Retatrutide is promising enough to be studied further in larger groups of people with type 2 diabetes.

Key takeaways

  • Study for type 2 diabetes involving a new weekly medicine.
  • Focuses on how the body handles low blood sugar (hypoglycemia).
  • It's an early-stage research study (Phase 1).
  • Open to adults aged 18 and over, both men and women.
  • Aims to understand the medicine's effects and safety.

Who may be eligible?

To be able to join this study, you need to be an adult, at least 18 years old. There's no upper age limit mentioned, so older adults can also take part. Both men and women are welcome to participate in this research.

The study is specifically for people who have been diagnosed with type 2 diabetes. It's important that your doctor has confirmed you have this type of diabetes for you to be considered for the study. The study doesn't mention other specific health conditions that might stop you from joining, but usually, a medical check-up will be done to make sure it's safe for 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 a diagnosis of type 2 diabetes?
  3. Are you comfortable with being closely monitored by doctors?
  4. Are you a man or a woman?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, Retatrutide, once a week. Because this is an early-stage study, you can expect to have regular visits to the clinic so that doctors and nurses can closely monitor your health and how you respond to the medicine. This will likely involve regular blood tests to check your blood sugar levels and other health markers, and physical examinations. You will also be asked to report any changes in how you feel. The total duration of your participation in the study, including the follow-up period after you stop taking the medicine, would be explained to you in detail before you decide to join.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving close medical attention and access to a new investigational medicine. However, there are also potential risks; new medicines can have unknown side effects, and some people might experience discomfort from blood tests or other procedures. You will be told about all known risks before you agree to participate and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Austria

Common questions

What is Retatrutide?

It's a new medicine being tested for people with type 2 diabetes. This study is trying to learn more about how it works.

What does 'hypoglycemia' mean?

Hypoglycemia is simply the medical term for when your blood sugar levels drop too low. It can make you feel shaky or dizzy.

Who can join this study?

Adults aged 18 and older, both men and women, who have type 2 diabetes can be considered for this study.

Is this a cure for diabetes?

No, this study is about understanding a new medicine to manage type 2 diabetes, not a cure.

What is a 'Phase 1' study?

Phase 1 is an early stage of testing a new medicine in people to learn how it works and if it's generally safe.

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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