All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes

This study is researching a new medicine, orforglipron, for individuals who are overweight or have obesity and also live with type 2 diabetes. The main goal is to understand how well orforglipron helps manage blood sugar levels compared to a placebo, which is a treatment without active medicine. This is a large-scale study, meaning it's in an advanced stage of testing. The study hopes to find out if orforglipron can be an effective new option for these conditions. Participants will be involved for about a year and a half, helping researchers gather important information about this potential new treatment.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
600
Start
19 May 2025
Estimated completion
01 Aug 2027

What is this study about?

This research study is looking at a new medicine called orforglipron. It's designed for people who are overweight or have obesity, and who also have type 2 diabetes. The main aim is to see if orforglipron can help them control their blood sugar levels better. This is compared to a 'placebo', which looks just like the real medicine but doesn't contain any active ingredients. Using a placebo helps researchers know for sure if any changes are due to the new medicine or something else.

Type 2 diabetes is a common condition where your body doesn't produce enough insulin, or the insulin it produces doesn't work properly. This means your blood sugar levels can get too high. Obesity and being overweight can make type 2 diabetes harder to manage. Finding new and effective ways to help people in this situation is really important.

This study is in an advanced stage, called 'Phase 3'. This means the medicine has already been tested in smaller groups, and now it's being tested on a larger number of people to confirm its benefits and understand more about its safety before it can potentially be made available to everyone. Your participation could help improve future treatments for people with these conditions.

Key takeaways

  • This study is testing a new medicine called orforglipron for type 2 diabetes and obesity/overweight.
  • It aims to see how well it controls blood sugar compared to a dummy medicine (placebo).
  • Participation lasts about 18 months and involves regular clinic visits.
  • It's for adults 18 and over who meet specific health requirements.
  • The study is in an advanced stage (Phase 3) to confirm its effectiveness and safety.
  • You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must be considered overweight or have obesity, and also have type 2 diabetes. Your doctor will check your blood sugar control using a test called HbA1c, and it needs to be within a certain range.

Also, you should have tried to lose weight through diet at least once before without success. This helps the researchers focus on people who are looking for new ways to manage their weight and blood sugar.

There are some reasons you might not be able to join. For example, if you have type 1 diabetes, specific severe heart conditions, ongoing liver or pancreas problems, or if you're already taking other medicines or remedies specifically for weight loss, this study might not be suitable 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. I am at least 18 years old.
  2. I have type 2 diabetes.
  3. I am considered overweight or have obesity.
  4. My blood sugar control (HbA1c) is between 7% and 10%.
  5. I have tried to lose weight through diet at least once before.
  6. I do not have type 1 diabetes or specific severe heart or liver conditions.
Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement in the study will last for about 18 months, which is about a year and a half. During this time, you will receive either the new medicine, orforglipron, or a placebo, which is a dummy medicine. You won't know which one you're getting, nor will the study team. You'll have regular visits to the study clinic for health checks, to take your study medicine, and to have various tests like blood tests to monitor your progress and make sure you're doing okay. The study team will explain everything in detail, including how often your visits will be and what each visit will involve.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving close medical attention and potentially getting access to a new medicine before it's widely available, which might help manage your blood sugar and weight. However, there are also potential risks, including side effects from the medicine, or the inconvenience of regular clinic visits and tests. It's important to remember that you will be closely monitored by medical professionals throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (80)

  • Clinical Research Institute of Arizona (CRI) - Sun City West
    Verified postcode
    Sun City West, United States
  • Novak Clinical Research - Tucson - North La Cholla Boulevard
    Verified postcode
    Tucson, United States
  • Norcal Endocrinology & Internal Medicine
    Verified postcode
    San Ramon, United States
  • Southern California Clinical Research
    Verified postcode
    Santa Ana, United States
  • Care Access - Thousand Oaks
    Verified postcode
    Thousand Oaks, United States
  • Accel Research Sites - DeLand Clinical Research Unit
    Verified postcode
    DeLand, United States
  • Innovation Medical Research Center - Fort Lauderdale
    Verified postcode
    Fort Lauderdale, United States
  • Indago Research & Health Center, Inc
    Verified postcode
    Hialeah, United States
  • Encore Medical Research
    Verified postcode
    Hollywood, United States
  • West Orange Endocrinology P.A.
    Verified postcode
    Ocoee, United States
  • Care Access - Tampa
    Verified postcode
    Tampa, United States
  • Conquest Research
    Verified postcode
    Winter Park, United States

Common questions

What is orforglipron?

Orforglipron is a new medicine being tested to see if it can help people with type 2 diabetes and obesity or who are overweight.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but doesn't have any active ingredients. It helps researchers compare how well the new medicine works.

How long does the study last?

If you join, you would be part of the study for about 18 months, which is roughly a year and a half.

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

Neither you nor the study team will know if you are receiving the real medicine or the placebo during the study. This is called 'blinding'.

Can I leave the study if I change my mind?

Yes, you can 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

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