Delving into the Latest Updates on NNC0113-6856 with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

pro-drug of semaglutide (Novo Nordisk), NN-9904, NN9904

+ [1]

Target

GLP-1R

Action

agonists

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/S

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.

Start Date04 Oct 2023

Sponsor / Collaborator

Novo Nordisk A/S

NCT05521256

/ CompletedPhase 1

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Oral Single Doses of NNC0113-6856 in Healthy Male Participants

In this study NN0113-6856 will be given to humans for the first time. We will be looking into how safe different single doses of the new investigational product NNC0113-6856 is and we will measure its amount as well as the amount of specific parts of the new investigational product in blood. The study will look at the effects of different single doses of NNC0113-6856. This could either be as an oral dose (cohort 1 to 5) or one injection into the vein (intravenous [IV]-cohort). Participant will get the investigational product either as one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (IV cohort). The study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by participants).

Start Date26 Aug 2022

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with NNC0113-6856

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100 Translational Medicine associated with NNC0113-6856

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100 Patents (Medical) associated with NNC0113-6856

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100 Deals associated with NNC0113-6856

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	Germany	Novo Nordisk A/S	26 Aug 2022

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Clinical Result

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Biosimilar

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