Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

J2A-MC-GZGQ: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

This research study, called ATTAIN-2, is investigating a new daily tablet for adults. Participants must be 18 or older, overweight or living with obesity, and also have type 2 diabetes. The tablet, named ORFORGLIPRON, is being tested against a placebo (a dummy pill that looks the same but contains no active medicine). The main goal is to find out how much weight people lose over 72 weeks while taking the new medicine, and to check for any side effects. This is a Phase 3 trial, which means it's one of the final steps before a medicine might be approved for wider use, and it's designed to confirm if the treatment is effective and safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Eli Lilly & Co.

Enrolment target

390

Start

19 Sep 2023

Overweight Obesity Type 2 Diabetes

What is this study about?

This study is looking into a new treatment for adults who are overweight or have obesity, and also live with type 2 diabetes. It's called ATTAIN-2, and its main purpose is to see if a new daily tablet, ORFORGLIPRON, can help people lose weight and if it's safe to use.

Type 2 diabetes is a condition where your body doesn't produce enough insulin or doesn't use it properly, leading to high blood sugar levels. Being overweight or having obesity can make it harder to manage type 2 diabetes. Finding new ways to help with weight management could also help improve diabetes control.

This is a 'Phase 3' study. This means the new medicine has already been tested in smaller groups of people, and now it's being tested in a larger group to make sure it works well and safely before it might become available more widely. Participants will be randomly given either the new medicine or a dummy pill, and neither they nor their doctors will know which one they are taking. This helps ensure the results are as fair and accurate as possible.

Key takeaways

Investigating a new daily tablet (ORFORGLIPRON) for weight loss.
For adults who are overweight or have obesity and type 2 diabetes.
Comparing the new tablet to a dummy pill (placebo) for safety and effectiveness.
Study duration is about 72 weeks (1 year and 5 months).
Participation involves regular clinic visits for health checks and blood tests.
You can withdraw from the study at any time without affecting your health care.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. There's no upper age limit specified.

You must also be diagnosed as being overweight or having obesity, and you need to have type 2 diabetes.

Both men and women can take part in this research. There will be other specific health checks to make sure the study is a good fit for you, but these are the main starting points.

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?
Have you been diagnosed as overweight or having obesity?
Do you have type 2 diabetes?
Are you able to attend regular clinic visits for about 72 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 72 weeks (around 1 year and 5 months). You'll have regular visits to the clinic where the study team will monitor your health, check your weight, and collect blood samples. You’ll be given either the study medication (ORFORGLIPRON) or a placebo (a dummy pill) to take once a day. You and your study doctor won't know whether you're taking the active medicine or the placebo. After your final dose, there will be a follow-up period to ensure your well-being.

Potential risks and benefits

Taking part in a study like this might have potential benefits if the new medicine helps with your weight and diabetes management, but there's no guarantee. You might also gain a deeper understanding of your health through the regular health checks. However, there could be risks of side effects from the medication, even if it's a dummy pill, or from the procedures involved like blood tests. All potential risks will be thoroughly explained to you, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Czechia
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Unverified
Germany
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Unverified
Greece

Common questions

What is a 'Phase 3' study?

A Phase 3 study is one of the final stages of testing a new medicine. It involves testing it in a large group of people to confirm its effectiveness and safety before it can be approved for general use.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare the effects of the new medicine accurately.

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

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you're receiving the active medicine or the placebo. This helps make the study results fair.

How long will the study last?

The study will last for approximately 72 weeks, which is about a year and a half, including follow-up after the treatment period.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without it affecting your medical care.