A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Purpose

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Condition

  • Bipolar Disorder

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II - 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 - Are on stable standard of care medication for bipolar disorder

Exclusion Criteria

  • Have a lifetime history or current diagnosis of the following according to DSM-5 criteria: - schizophrenia or other psychotic disorder - borderline personality disorder, or - any eating disorder - Have type 1 diabetes mellitus, or a history of - ketoacidosis, or - hyperosmolar state or coma - 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 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brenipatide Dose 1 		Brenipatide administered subcutaneous (SC) + SoC.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Experimental
Brenipatide Dose 2 . 		Brenipatide administered subcutaneous (SC) + SoC.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Placebo Comparator
Placebo 		Placebo administered SC + SoC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

ATP Clinical Research
Orange, California 92866
Contact:
949-354-5353

Yale University School of Medicine
New Haven, Connecticut 06519
Contact:
203-932-5711

AGA Clinical Trials
Hialeah, Florida 33012
Contact:
3058196990 X 1

Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida 32751
Contact:
386-785-2400

K2 Medical Research - Maitland
Maitland, Florida 32751

Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
Contact:
305-330-9977

CLA Research
Naples, Florida 34116
Contact:
239-837-8818

Charter Research - Orlando
Orlando, Florida 32803

Encore Medical Research - Weston
Weston, Florida 33331
Contact:
954-777-8827

Atlanta Center for Medical Research
Atlanta, Georgia 30331

Covenant Medical Center
Waterloo, Iowa 50702
Contact:
319-272-2112

CBH Health
Gaithersburg, Maryland 20877
Contact:
301-251-4702

Elixia MA
Springfield, Massachusetts 01103
Contact:
413-305-1142

Adams Clinical Watertown
Watertown, Massachusetts 02472
Contact:
617-744-8542

Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104

Revival Research Institute, LLC
McKinney, Texas 75071

Pillar Clinical Research - Richardson
Richardson, Texas 75080
Contact:
214-396-4844

Alpine Research Organization
Clinton, Utah 84015
Contact:
801-928-3292

Re:Cognition Health
Fairfax, Virginia 22031

Northwest Clinical Research Center
Bellevue, Washington 98007
Contact:
425-453-0404

SCB Research Center
Bayamón, Puerto Rico 00961
Contact:
(787) 798-4592

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com