Recent Updates
Recently added Catalysts

ZGN-1061

Phase 2

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

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment188
FDA Designations
No designations recorded
Clinical trial landscape

ZGN-1061 · 1 trial · 2 indications

Phase 2 1
NCT03254368Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED188 Analytics
PHASE2COMPLETED
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Type 2 Diabetes Mellitus
NCT03254368188
Unlock trial analytics
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 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
Unlock Eligibility Criteria