Delving into the Latest Updates on NNC0581-0001 with Synapse

Overview

Basic Info

Drug Type

siRNA

Synonyms

NN-6581, NN6581, NNC0581 0001

+ [1]

Target

MTARC1

Action

modulators

Mechanism

MTARC1 modulators(mitochondrial amidoxime reducing component 1 modulators)

Therapeutic Areas

Digestive System Disorders

Active Indication

Nonalcoholic Steatohepatitis

Inactive Indication-

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/S

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure/Sequence

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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.

Start Date12 Mar 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT05599945

/ Active, not recruitingPhase 1

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.

Start Date23 Nov 2022

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with NNC0581-0001

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100 Translational Medicine associated with NNC0581-0001

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100 Patents (Medical) associated with NNC0581-0001

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100 Deals associated with NNC0581-0001

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