RecruitingPHASE3INTERVENTIONAL

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

This research study is investigating a new medication called Brenipatide for adults who experience major depression. The main goal is to find out if Brenipatide, when given alongside the treatments people usually receive for depression, is safe and effective at preventing their symptoms from returning. It will be compared to people receiving a dummy medicine (placebo) with their usual care. The study involves different stages, including a screening period to check if you're suitable, a treatment period usually lasting at least 12 months, and a final follow-up. This helps researchers understand how Brenipatide might help people manage their depression.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,000

Start

09 Feb 2026

Estimated completion

01 Feb 2028

Depressive Disorder, Major

What is this study about?

This study is called "A Study of Brenipatide in Adult Participants With Major Depressive Disorder." Its main purpose is to see how well a new medicine, Brenipatide, works for adults who have major depression. Researchers want to find out if taking Brenipatide, along with the treatments you normally receive (this is called 'standard of care'), can help stop your depression symptoms from coming back as quickly or as often. They will compare this to people who receive a dummy medicine (a placebo) alongside their usual care.

Major depression is a common illness that can significantly affect daily life. Finding new ways to manage and prevent symptoms from returning is very important for many people. This study aims to add to current understanding and potentially offer a new treatment option.

By comparing Brenipatide to a placebo, with both groups also receiving their standard care, the researchers can see if any improvements are genuinely due to the new medicine rather than other factors. This helps ensure that any future treatments are proven to be safe and effective.

Key takeaways

The study is testing a new medicine, Brenipatide, for major depression.
It aims to see if Brenipatide can help stop depression symptoms from returning.
You will receive either Brenipatide or a dummy medicine (placebo) alongside your usual care.
The study involves regular visits, taking medication, and keeping records.
Participation lasts at least 12 months for the treatment period, plus screening and follow-up.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with major depression. You should already be receiving stable treatment for your depression, meaning your current medication has been at a steady dose for a while.

You'll also need to be willing to follow the study's rules. This includes being able to give yourself injections of the study medicine, keep accurate records, fill out questionnaires, and attend all scheduled appointments. It's important to be reliable and committed to seeing the study through.

There are also reasons why you might not be able to join. For example, if you have ever had conditions like schizophrenia, bipolar disorder, certain eating disorders, or type 1 diabetes. Also, if you have had problems with alcohol or drug use in the last six months, or if you are currently at a high risk of harming yourself, you wouldn't be able to take part. If you've recently been part of another clinical study, that might also prevent you from joining.

Quick self-check

Are you between 18 and 75 years old?
Do you have a diagnosis of major depression?
Are you currently on stable treatment for your depression?
Are you able to give yourself injections and keep accurate records?
Do you NOT have conditions like bipolar disorder, schizophrenia, or type 1 diabetes?
Have you NOT had serious substance or alcohol use problems in the last 6 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will involve several stages. First, there's a 'screening period' which lasts about one month; during this time, doctors will check if the study is right for you. If you qualify, you'll then enter the 'treatment period,' where you'll receive either Brenipatide or a placebo. This period will last for at least 12 months. After that, there will be a 'follow-up period' of about two months to see how you're doing.

Throughout the study, you'll be expected to come to regular doctor's visits, complete questionnaires, and keep diaries, possibly on paper or electronically. You will also need to be able to give yourself the study medicine as an injection. The total time you spend in the study can vary and might be shorter if your depression symptoms get worse, or if you decide to leave the study at any point.

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 experimental medicine before it's widely available. However, there are also potential risks, including side effects from the medication (whether it's Brenipatide or the placebo) and the time commitment involved. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (186)

Accellacare - Moorpark
Moorpark, United States· Not yet recruiting
ATP Clinical Research
Orange, United States· Recruiting
Yale University School of Medicine
New Haven, United States· Not yet recruiting
Encore Medical Research
Hollywood, United States· Not yet recruiting
K2 Medical Research - Maitland
Maitland, United States· Not yet recruiting
Life Medical Research Group Corp
Miami Gardens, United States· Recruiting
Floridian Clinical Research, LLC
Miami Lakes, United States· Not yet recruiting
CLA Research
Naples, United States· Not yet recruiting
Optimal Research Sites
Orange City, United States· Recruiting
Charter Research - Orlando
Orlando, United States· Recruiting
K2 Medical Research - Tampa
Tampa, United States· Not yet recruiting
CenExel iResearch, LLC
Decatur, United States· Recruiting

+174 more sites — see the official record for the full list.

Common questions

What is Brenipatide?

Brenipatide is an experimental medicine being tested in this study to see if it can help prevent depression symptoms from returning in adults with major depression.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the active medicine fairly.

Will I know if I'm getting Brenipatide or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study staff will know whether you are receiving Brenipatide or the placebo. This helps ensure the results are unbiased.

How long will I be in the study?

The study has a screening period (about 1 month), a treatment period (at least 12 months), and a follow-up period (about 2 months). The total time you spend in the study may vary.

Can I leave the study early?

Yes, 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

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.