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ZGN-1061

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Larimar Therapeutics, Inc.|Last Updated: May 24, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment188
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03254368Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 DiabetesPHASE2 COMPLETED 188Sep 12, 2017Feb 22, 2019May 24, 201923 Australia, New Zealand
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Study Endpoints
Primary Endpoints
Change in HbA1c
12 weeks
Safety and tolerability as assessed by incidence of adverse events
12 weeks
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
12 weeks
Secondary Endpoints
Change in body weight
12 weeks
Change in fasting plasma glucose
12 weeks
Change in insulin
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
0.05 mg ZGN-1061 (A)EXPERIMENTAL0.05 mg ZGN-1061 subcutaneous injection once every 3 days
0.3 mg ZGN-1061 (B)EXPERIMENTAL0.3 mg ZGN-1061 subcutaneous injection once every 3 days
0.9 mg ZGN-1061 (C)EXPERIMENTAL0.9 mg ZGN-1061 subcutaneous injection once every 3 days
1.8 mg ZGN-1061 (CC)EXPERIMENTAL1.8 mg ZGN-1061 subcutaneous injection once every 3 days
Placebo (D)PLACEBO_COMPARATORPlacebo subcutaneous injection once every 3 days
Interventions
NameTypeDescription
ZGN-1061DRUGZGN-1061 is a methionine aminopeptidase 2 inhibitor
PlaceboDRUGPlacebo has the same excipients and appearance as ZGN-1061
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: Subjects must meet the following criteria to participate in this study: * Be between the ages of 18 and 70 years, inclusive. * Overweight or obese with a body mass index of at least 27 kg/m². * Have type 2 diabetes with HbA1c between 7% and 11%. * For subjects taking approved a...

Countries:AustraliaNew Zealand
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