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ZGN-433

Phase 1

Obesity | Small molecule | Metabolic |Larimar Therapeutics, Inc.|Last Updated: Jan 11, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

ZGN-433 · 2 trials · 1 indication

Phase 1 2
NCT01372761Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female VolunteersObesity
COMPLETED25 Analytics
NCT01028261Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female VolunteersObesity
COMPLETED31 Analytics
PHASE1COMPLETED
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
ObesityUnlock trial analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
Approximately 4 weeks

Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.

Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
Approximately 2 months

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-433 to assess relationship to weight loss.
Approximately 4 weeks
Elimination half-life of ZGN-433 to assess relationship to weight loss.
Approximately 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Normal SalinePLACEBO_COMPARATOR -
ZGN-433EXPERIMENTAL -

Interventions

NameTypeDescription
ZGN-433DRUGSubjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Normal SalineDRUGSubjects will receive placebo or ZGN-433 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 ≤ 50 kg/m2 * Stable body weight during the past month Exclusion Criteria: * Use of ...

Countries:Australia
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Frequently asked questions about ZGN-433

What is ZGN-433 used for?

ZGN-433 is an investigational small molecule being developed for the treatment of obesity. It is a metabolic therapeutic that has been studied in Phase 1 clinical trials in obese female volunteers. The drug is not yet approved and remains in clinical development.

Who makes ZGN-433?

ZGN-433 is being developed by Larimar Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LRMR. The company has conducted Phase 1 clinical trials of ZGN-433 in Australia.

What phase is ZGN-433 in?

ZGN-433 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving obese female volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ZGN-433 in?

ZGN-433 has completed two Phase 1 clinical trials. The first, NCT01028261, studied multiple doses in 31 obese female volunteers. The second, NCT01372761, studied intravenous doses in 25 obese female volunteers. Both trials were conducted in Australia.

Is ZGN-433 the same as ZGN-433?

ZGN-433 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial records. It is a small molecule therapeutic being developed for obesity.