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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

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Market & Valuation

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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 MellitusUnlock 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
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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 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
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Frequently asked questions about ZGN-1061

What is ZGN-1061 used for?

ZGN-1061 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is being studied in overweight and obese participants with Type 2 Diabetes. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes ZGN-1061?

ZGN-1061 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 effects and safety in patients with Type 2 Diabetes Mellitus.

What phase is ZGN-1061 in?

ZGN-1061 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency, and its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is ZGN-1061 in?

ZGN-1061 has one completed Phase 2 clinical trial, registered under NCT03254368. The study assessed the effects and safety of ZGN-1061 in overweight and obese participants with Type 2 Diabetes. The trial enrolled 188 participants and was conducted in Australia and New Zealand.

Is ZGN-1061 FDA approved?

ZGN-1061 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. A Phase 2 trial has been completed, but the drug has not yet received marketing approval from the FDA or other regulatory bodies.

What is the trial design for ZGN-1061?

The completed Phase 2 trial for ZGN-1061 was a randomized, double-blind, placebo-controlled study. It enrolled 188 participants with Type 2 Diabetes Mellitus who were overweight or obese. The trial was conducted at sites in Australia and New Zealand and included adults aged 18 years and older.