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Looking for participantsPhase3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Sponsor: Eli Lilly and Company

NCT ID: NCT07412756

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Brenipatide (drug), Placebo (drug)
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
Brenipatide — drug: Administered SC · Placebo — drug: Administered SC
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 75 Years
Who
All
Number of participants
1,000
Started
2026-02-09
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for depressive disorder, major
  • • Phase3 - 1,000 participants
  • • This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms

Who can take part?

  • • Ages 18 Years to 75 Years
  • • Diagnosed with depressive disorder, major

Where?

  • • Edinburgh - Edinburgh Royal Infirmary
  • • Exeter - Devon Partnership Trust
  • • Glasgow - Queen Elizabeth University Hospital
  • • London - The Maudsley Hospital
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into four periods as follows: a screening period that will last approximately 1 month, a treatment period with a potential post treatment period that combined will last a minimum of 12 months, and the follow up period that will last approximately 2 months.

Depressive Disorder, Major

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 75 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ study visits, and are willing and able to follow study procedures as required, such as
  • ✓ questionnaires

What the study is looking for

  • ✓Meet the diagnostic criteria for major depressive disorder
  • ✓Are on a stable the usual treatment medication for major depressive disorder
  • ✓Are reliable and willing to make themselves available for the duration of the study and attend required study...
  • ✓self-inject study intervention
  • ✓store and use the provided blinded study intervention, as directed

Who cannot take part

  • ✗Have a lifetime history or current diagnosis of the following:
  • ✗schizophrenia or other psychotic disorder
  • ✗bipolar disorder
  • ✗borderline personality disorder, or
  • ✗any eating disorder.
See the full criteria
Inclusion Criteria: * Meet the diagnostic criteria for major depressive disorder * Are on a stable standard of care medication for major depressive disorder * Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as * self-inject study intervention * store and use the provided blinded study intervention, as directed * maintain electronic and paper study diaries, as applicable, and * complete the required questionnaires Exclusion Criteria: * Have a lifetime history or current diagnosis of the following: * schizophrenia or other psychotic disorder * bipolar disorder * borderline personality disorder, or * any eating disorder. * Have type 1 diabetes mellitus, or a history of * ketoacidosis, or * hyperosmolar state or coma. * Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening * Are actively suicidal or deemed a significant risk for suicide * Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Where Is This Study? (10 UK sites)

Edinburgh Royal Infirmary

Edinburgh EH16 4SA, United Kingdom

Recruiting
Site contact (verified)
Donald MacIntyrePrincipal Investigator

Devon Partnership Trust

Exeter EX2 5AF, United Kingdom

Recruiting
Site contact (verified)
Merryn AndersonPrincipal Investigator

Queen Elizabeth University Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Nagore PenadesPrincipal Investigator

The Maudsley Hospital

London SE5 8AZ, United Kingdom

Recruiting
Site contact (verified)
Allan YoungPrincipal Investigator

Clerkenwell Health - London - Welbeck Street

London W1G 8DR, United Kingdom

Recruiting
Site contact (verified)
Alishah SulemanPrincipal Investigator

Queen's Medical Centre, Nottingham University Hospitals

Nottingham NG7 2UH, United Kingdom

Recruiting
Site contact (verified)
Neil NixonPrincipal Investigator

Warneford Hospital

Oxford OX3 7JX, United Kingdom

Recruiting
Site contact (verified)
Riccardo De GiorgiPrincipal Investigator

St Bartholomew's Medical Centre

Oxford OX4 1XB, United Kingdom

Recruiting
Site contact (verified)
Carol DoanPrincipal Investigator

Atlantic Medical

Penzance TR18 3DX, United Kingdom

Recruiting
Site contact (verified)
John RyanPrincipal Investigator

Woodstock Bower Surgery

Rotherham S61 1AH, United Kingdom

Recruiting
Site contact (verified)
Shahbaz AliPrincipal Investigator

How to Get in Touch

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

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09