Not yet recruitingPHASE3INTERVENTIONAL

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder

This research study is investigating a new potential medication, Brenipatide, for adults experiencing major depression. The main goal is to find out if this new treatment, given alongside your usual care, can effectively delay the return of depression symptoms compared to a dummy treatment (placebo) combined with your usual care. Researchers will also look at how safe the new medication is. Participants will receive either Brenipatide or the placebo, and the study will last at least 15 months, including screening and follow-up. This type of study helps scientists understand if new treatments are safe and effective before they can become widely available.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

1,000

Start

01 Aug 2026

Estimated completion

01 Feb 2029

Depressive Disorder, Major

What is this study about?

This clinical trial is designed to see if a new medicine, called Brenipatide, could help people who suffer from major depression. It aims to understand if adding Brenipatide to the standard care you already receive can prevent depression symptoms from returning. Researchers will compare this new medicine to a 'placebo', which looks like the medicine but contains no active drug, also given alongside your standard care.

Taking part in this study means you would be randomly assigned to either receive Brenipatide or the placebo. Neither you nor your study doctor will know which one you are receiving – this is to make sure the results are fair and unbiased. The study will carefully monitor your health and depression symptoms throughout. This type of research is crucial because it helps us discover new and potentially better ways to treat conditions like major depression, offering hope for more effective solutions in the future.

By comparing the new medicine to a placebo, scientists can determine if Brenipatide truly makes a difference. It's an important step in the process of developing new treatments and making sure they are safe and work well for patients. Your involvement could help countless others with major depression in the future.

Key takeaways

This study is testing a new medication (Brenipatide) for major depression.
It compares the new medicine plus usual care to a dummy treatment (placebo) plus usual care.
The main aim is to see if Brenipatide can stop depression symptoms from returning.
Participation involves self-injections, keeping diaries, and attending regular appointments.
The study lasts a minimum of 15 months, including screening and follow-up.
You can stop participating at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, you must be an adult aged between 18 and 75 years old and have a confirmed diagnosis of major depression. It's also important that you are already receiving standard care medication for your depression and that your treatment has been stable.

You would need to be able to follow the study instructions carefully, including giving yourself injections, keeping a diary of your experiences, and filling out questionnaires. You should also be able to attend all the required study appointments.

There are some reasons why you wouldn't be able to join. For example, if you have ever been diagnosed with certain other mental health conditions like bipolar disorder or schizophrenia, or if you have specific medical conditions such as type 1 diabetes, or certain substance or alcohol use disorders. You also can't be actively suicidal or have recently taken part in another clinical study where you received an active treatment.

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 between 18 and 75 years old?
Do you have a diagnosis of major depression?
Are you currently on stable medication for your depression?
Are you comfortable giving yourself injections?
Can you commit to regular study visits and keeping a diary?
Do you have any history of bipolar disorder, schizophrenia, type 1 diabetes, or severe substance abuse?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would last for a minimum of 15 months, though this could be shorter if your depression worsens or you decide to leave the study early. This time is split into three main parts:

* **Screening Period (about 1 month):** This is when doctors check if you're a good fit for the study. You'll have appointments to review your health and depression history. * **Treatment Period (at least 12 months):** If you qualify, you'll receive either the new medication (Brenipatide) or a dummy treatment (placebo) for at least a year. You'll give yourself injections and carefully record your symptoms and experiences in a diary. You'll also attend regular visits at the study clinic. * **Follow-up Period (about 2 months):** After your treatment ends, there will be a short period where doctors continue to check on your health and well-being. Throughout the study, you'll be asked to complete questionnaires and attend all scheduled appointments.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of trying a new treatment that could improve your symptoms, even if you receive the placebo, as you will be closely monitored by medical professionals. However, there are potential risks, just like with any medication, such as side effects from the study drug or the possibility that the treatment may not work for you. 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 (169)

University of Alabama at Birmingham - School of Medicine
Verified postcode
Birmingham, United States
NoesisPharma, LLC
Verified postcode
Phoenix, United States
Irvine Clinical Research
Verified postcode
Irvine, United States
Healthy Brain Clinic
Verified postcode
Long Beach, United States
Oakland Clinical
Verified postcode
Oakland, United States
Concierge Clinical Trials
Verified postcode
Valley Village, United States
JEM Research Institute
Verified postcode
Atlantis, United States
Bradenton Research Center, Inc.
Verified postcode
Bradenton, United States
Key Clinical Research
Verified postcode
Bradenton, United States
NextPhase Research Florida - Hollywood
Verified postcode
Hollywood, United States
Miami Jewish health
Verified postcode
Miami, United States
Quantix Research - Miami - Southwest 72nd Street
Verified postcode
Miami, United States

Common questions

What is 'standard of care' medication?

Standard of care medication means the usual, accepted treatments that doctors currently recommend and prescribe for major depression.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the real medication but contains no active drug. It helps researchers see if the new medicine truly works better than doing nothing or having the expectation of treatment.

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

No, you won't know, and neither will your study doctor. This is called 'blinding' and it helps make sure the results are as fair and accurate as possible.

How long will I need to be in the study?

The study involves a screening period of about one month, a treatment period of at least 12 months, and a follow-up period of about two months, making the total time a minimum of 15 months.

What if I feel worse during the study?

Your safety and well-being are a top priority. You will be closely monitored, and if your depression symptoms worsen or you have any concerns, you can withdraw from the study at any time.

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.