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ZGN-440

Phase 1

Obesity | Small molecule | Metabolic |Larimar Therapeutics, Inc.|Last Updated: Jul 18, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

ZGN-440 · 1 trial · 1 indication

Phase 1 1
NCT01507077ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of ObesityObesity
COMPLETED25 Analytics
PHASE1COMPLETED
ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers.
Approximately 4 weeks

Measures of the safety and tolerability of ZGN-440 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.

Secondary Endpoints

Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
Approximately 4 weeks
Peak plasma concentration of ZGN-440 to assess relationship to weight loss.
Approximately 4 weeks
Elimination half-life of ZGN-440 to assess relationship to weight loss.
Approximately 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZGN-440 sterile diluentPLACEBO_COMPARATOR -
ZGN-440EXPERIMENTAL -

Interventions

NameTypeDescription
ZGN-440DRUGSubjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
ZGN-440 sterile diluentDRUGSubjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Obese but otherwise healthy females * Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months) * BMI ≥ 30 and ≤ 45 kg/m2 * Stable body weight during the past 2 months Exclusion Criteria: * Use ...

Countries:Australia
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Frequently asked questions about ZGN-440

What is ZGN-440 used for?

ZGN-440 is an investigational small molecule being developed for the treatment of obesity. It is administered by subcutaneous injection and is intended for use in metabolic conditions. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes ZGN-440?

ZGN-440 is being developed by Larimar Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LRMR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating obesity.

What phase is ZGN-440 in?

ZGN-440 is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the drug in 25 participants with obesity. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is ZGN-440 in?

ZGN-440 has one completed Phase 1 clinical trial registered under NCT01507077, titled 'ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity.' The trial enrolled 25 female participants aged 18 years and older in Australia and was a randomized, double-blind, placebo-controlled study.

Is ZGN-440 the same as beloranib?

Yes, ZGN-440 is also known as beloranib. The clinical trial NCT01507077 refers to the drug as 'ZGN-440 (Beloranib for Subcutaneous Injection),' confirming that ZGN-440 and beloranib are the same investigational compound being studied for obesity.