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Glial growth factor 2/ Neuregulin 1β3

Phase 1

Heart Failure | Small molecule | Cardiovascular |cbdMD, Inc.|Last Updated: Jul 1, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Glial growth factor 2/ Neuregulin 1β3 · 1 trial · 1 indication

Phase 1 1
NCT01258387Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart FailureHeart Failure
COMPLETED40 Analytics
PHASE1COMPLETED
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
6 months

Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.

Secondary Endpoints

Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
Screening, day 8, day 14, day 28, and 3 months post-dose
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
Screening, day 8, day 14, day 28, and 3 months post-dose
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
Screening, day 8, day 14, day 28, and 3 months post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GGF2PLACEBO_COMPARATORSeven dosing cohorts: 2 patients randomized to receive 1 GGF2, 1 placebo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed

Interventions

NameTypeDescription
Glial growth factor 2/ Neuregulin 1β3DRUG -
PlaceboOTHER -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Left ventricular ejection fraction (LVEF) between 10% and 40%. 2. Male or female, aged 18 to 75 years, inclusive. Exclusion Criteria: 1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30...

Countries:United States
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Frequently asked questions about Glial growth factor 2/ Neuregulin 1β3

What is Glial growth factor 2/ Neuregulin 1β3 used for?

Glial growth factor 2/ Neuregulin 1β3 is an investigational small molecule being developed for the treatment of heart failure. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in patients.

Who makes Glial growth factor 2/ Neuregulin 1β3?

Glial growth factor 2/ Neuregulin 1β3 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical research to evaluate this drug candidate for heart failure.

What phase is Glial growth factor 2/ Neuregulin 1β3 in?

Glial growth factor 2/ Neuregulin 1β3 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is still in early-stage clinical trials to assess its safety and tolerability in patients with heart failure.

What clinical trials is Glial growth factor 2/ Neuregulin 1β3 in?

Glial growth factor 2/ Neuregulin 1β3 has one completed clinical trial, identified as NCT01258387. This Phase 1 study, titled 'Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure,' enrolled 40 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is Glial growth factor 2/ Neuregulin 1β3 the same as GGF2?

Yes, Glial growth factor 2/ Neuregulin 1β3 is also known as GGF2. The clinical trial NCT01258387 refers to the drug as GGF2, and it is being studied for the treatment of heart failure. Both names refer to the same investigational drug candidate.