Brenipatide for Bipolar Disorder

Recruiting at 85 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Standard care bipolar

Disqualifiers: Schizophrenia, Borderline, Eating disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of brenipatide, an experimental treatment, in managing bipolar disorder symptoms alongside usual treatments. Participants will receive either one of two doses of brenipatide or a placebo (a non-active substance) in addition to their regular care. Suitable candidates have been diagnosed with bipolar disorder I or II, are stable on their current medications, and can follow study instructions, such as self-injecting the treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in managing bipolar disorder.

Will I have to stop taking my current medications?

The trial requires participants to be on stable standard of care medication for bipolar disorder, so you will not need to stop taking your current medications.

Is there any evidence suggesting that brenipatide is likely to be safe for humans?

Research has shown that a similar drug to brenipatide, called tirzepatide, was well-tolerated in past studies. Most people using tirzepatide experienced mild and short-lived side effects, suggesting that brenipatide might also be safe for humans.

Although some reports noted mental health side effects, these were less common with tirzepatide than with other similar drugs. This is encouraging, but the safety of brenipatide for treating bipolar disorder remains under study. Participants should discuss potential risks with their healthcare providers before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar disorder?

Brenipatide is unique because it offers a new approach for managing bipolar disorder by being administered subcutaneously (under the skin), unlike many current treatments taken orally. Researchers are excited about its potential to work alongside the standard of care (SoC) to enhance treatment effectiveness. Furthermore, Brenipatide might provide a different mechanism of action, potentially targeting symptoms in a novel way compared to existing medications, which often focus on balancing neurotransmitters. This innovative approach could offer fresh hope for patients who don't fully benefit from current options.

What evidence suggests that brenipatide might be an effective treatment for bipolar disorder?

In earlier studies, tirzepatide, a drug similar to brenipatide, showed promising results for improving mood. Patients felt happier and slept better just a few days after increasing their dose. Tirzepatide also helped people with bipolar disorder manage emotional eating. This suggests that brenipatide, currently under trial, might help stabilize mood and improve emotional control in people with bipolar disorder. However, more research is needed to confirm these effects specifically for brenipatide. ^{2 3 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with bipolar disorder can join this trial. They'll be taking Brenipatide or a placebo alongside their usual treatments to see if it helps delay the worsening of symptoms. The study includes about 1 month of screening, at least 6 months of treatment, and roughly 2 months follow-up.

Inclusion Criteria

I can commit to the study schedule, follow instructions for self-injection, and keep accurate records.

I have been diagnosed with bipolar disorder I or II.

I am on a stable medication regimen for bipolar disorder.

Exclusion Criteria

Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening

Are actively suicidal and or deemed to be at significant risk for suicide

Have a lifetime history or current diagnosis of schizophrenia or other psychotic disorder, borderline personality disorder, or any eating disorder according to DSM-5 criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive brenipatide or placebo administered subcutaneously along with standard of care to assess efficacy and safety in delaying bipolar disorder symptoms

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brenipatide

Trial Overview

The trial is testing Brenipatide's effectiveness and safety in adults with bipolar disorder when taken with standard care versus a placebo plus standard care. It aims to see if Brenipatide can help prevent symptoms from getting worse over time.

How Is the Trial Designed?

Group I: Brenipatide Dose 2 . Experimental Treatment 1 Intervention

Brenipatide administered subcutaneous (SC) + SoC.

Group II: Brenipatide Dose 1 Experimental Treatment 1 Intervention

Brenipatide administered subcutaneous (SC) + SoC.

Group III: Placebo Placebo Group 1 Intervention

Placebo administered SC + SoC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

psychiatrist.com

psychiatrist.com/pcc/mental-health-effects-tirzepatide-report-2-patients/

Mental Health Effects of Tirzepatide: A Report of 2 Patients

At 8 weeks, the tirzepatide dose was increased to 5 mg, leading to rapid improvement in mood within a few days. Sleep also improved along with ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10960895/

Psychiatric adverse events associated with semaglutide ...

Nine deaths (8 with liraglutide and 1 with semaglutide) and 11 life-threatening outcomes (4 associated with liraglutide and 7 with semaglutide) were reported.

3.

media.sciltp.com

media.sciltp.com/articles/2511002379/2511002379.pdf

Tirzepatide and Eating Behaviors in Patients with Bipolar ...

We observed significant improvements in cognitive restraint, emotional eating, and uncontrolled eating. These findings encourage larger-scale ...

4.

nature.com

nature.com/articles/s41591-023-02597-w

Tirzepatide after intensive lifestyle intervention in adults ...

Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0924977X2500803X

Association between tirzepatide use and risk of mortality ...

This study aimed to evaluate the real-world effectiveness and psychiatric safety of tirzepatide among adults with schizophrenia spectrum disorders, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12667738/

Association of tirzepatide and the risk of suicide in a real-world ...

Over a median follow-up of 365 days, 17 tirzepatide patients and 33 control patients experienced suicidal ideation or attempts.

7.

sciltp.com

sciltp.com/journals/ewjpmh/articles/2511002379

Beyond Weight Loss: Tirzepatide and Eating Behaviors in ...

Tirzepatide was generally well tolerated, with only mild and transient adverse effects. These results suggest that tirzepatide may provide benefits extending ...