Active not recruitingPHASE3INTERVENTIONAL

A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

This research is looking at a new medicine called orforglipron to help people with high blood pressure who are also overweight or living with obesity. High blood pressure can lead to serious health problems, so finding new ways to manage it is important. This study aims to find out if orforglipron is safe and effective in lowering blood pressure. Participants will be given either the new medicine or a placebo, which looks like the medicine but contains no active ingredients. This helps researchers compare the effects accurately. The study is particularly interested in how the medicine works in people who also have excess weight, as these conditions often occur together. This is a crucial step in understanding if orforglipron could become a future treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

974

Start

30 Apr 2025

Estimated completion

01 Sep 2027

Hypertension

What is this study about?

This study is a research project designed to explore a new medicine called orforglipron. The main goal is to see if this medicine can help people who have high blood pressure, especially if they are also overweight or living with obesity. High blood pressure means your heart has to work extra hard, and over time, this can cause problems like heart attacks or strokes. Many people who are overweight or have obesity also experience high blood pressure, so a medicine that could help with both would be really beneficial.

The study will compare orforglipron with a 'placebo.' A placebo looks exactly like the actual medicine but doesn't contain any active ingredients. This is a standard way to test new medicines, as it helps researchers properly understand if the changes they see are because of the medicine itself or for other reasons. Neither you nor your study doctor will know whether you are receiving the active medicine or the placebo, which helps keep the study fair and unbiased.

By taking part, you would be helping doctors and scientists learn more about orforglipron. This information is vital for deciding if this medicine could one day be a safe and effective treatment option for many people. Your contribution could make a real difference in how high blood pressure and obesity are managed in the future.

Key takeaways

This study is testing a new medicine called orforglipron for high blood pressure.
It's for adults who also have a BMI of 25 or higher (overweight or obesity).
Some participants will get the actual medicine, and others will get a dummy pill (placebo).
The main aim is to see if the medicine is safe and effective in lowering blood pressure.
Your participation could help advance our understanding of treating these conditions.

Who may be eligible?

To join this study, you would need to be 18 years old or older. You must have high blood pressure, specifically a top number (systolic) of 140 mmHg or more, or a bottom number (diastolic) of 90 mmHg or more. If only your bottom number is high, your top number must still be 130 mmHg or more.

It's important that you're either not currently taking blood pressure medicine, or you've been on a steady dose of your current medicine for at least 30 days before the study starts. You also need to have a Body Mass Index (BMI) of 25 or higher, which indicates you are overweight or have obesity.

There are also reasons why you might not be able to join. For example, if your blood pressure is extremely high (170/110 mmHg or more), or if your high blood pressure is caused by another condition. You also couldn't take part if you've recently been in hospital for high blood pressure or heart failure, or if you've had a heart attack, serious heart problem, or stroke in the last 90 days. People with type 1 diabetes or certain liver conditions would also not be able to join 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 18 years old or older?
Do you have high blood pressure (e.g., top number 140 or more, or bottom number 90 or more)?
Are you overweight or living with obesity (BMI of 25 or higher)?
Have you been on a stable dose of your blood pressure medicine for at least 30 days, or not taking any currently?
Have you avoided a heart attack, stroke, or hospitalisation for high blood pressure in the last 3 months?
Do you have Type 1 diabetes or certain liver conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would start with a screening visit to check if you meet all the requirements. If you do, you'd then have regular visits to the clinic. During these visits, the study team would measure your blood pressure, and you would receive either the study medicine (orforglipron) or a placebo. You would also have other tests, like blood samples, to monitor your health and how the medicine is affecting you.

The study would last for a period of time that the study team will explain to you, involving these regular check-ups and taking the assigned medication. It's important to attend all scheduled appointments so the researchers can gather accurate information and monitor your well-being. The total duration of your involvement, including all visits and follow-ups, would be clearly explained before you agree to participate.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. One potential benefit is that you might receive access to a new medicine that could help manage your high blood pressure and weight. You would also receive close medical attention and monitoring from the study team. However, the medicine might not work for you, or you might receive a placebo. Possible risks could include side effects from the medicine, which would be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (100)

Elite Clinical Studies, LLC
Verified postcode
Phoenix, United States
Valley Clinical Trials, Inc.
Verified postcode
Covina, United States
Valley Clinical Trials, Inc.
Verified postcode
Northridge, United States
Chase Medical Research, LLC
Verified postcode
Waterbury, United States
Excel Medical Clinical Trials
Verified postcode
Boca Raton, United States
Care Access - Brandon
Verified postcode
Brandon, United States
Northeast Research Institute - Downtown Office
Verified postcode
Jacksonville, United States
Care Access - St. Petersburg
Verified postcode
St. Petersburg, United States
East-West Medical Research Institute
Verified postcode
Honolulu, United States
Sinai Hospital Of Baltimore
Verified postcode
Baltimore, United States
Ascension Saint Agnes Heart Care
Verified postcode
Baltimore, United States
Lucida Clinical Trials
Verified postcode
New Bedford, United States

Common questions

What is high blood pressure?

High blood pressure means the force of your blood pushing against your artery walls is consistently too high, which can be harmful over time.

What is a placebo?

A placebo is a 'dummy pill' that looks like the real medicine but contains no active ingredients. It's used to compare against the new medicine.

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

No, neither you nor your study doctor will know what you are receiving. This is called 'blinding' and helps keep the study fair.

Why is this study focusing on people who are overweight or have obesity?

High blood pressure and excess weight often go hand-in-hand, so researchers want to see how this new medicine specifically works for people with both conditions.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time for any reason, and it won't affect your regular medical care.