Recent Updates
Recently added Catalysts

NNC0113-6861

Phase 1

Type 2 Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Apr 27, 2023

NNC0113-6861 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

NNC0113-6861 clinical trials

NNC0113-6861 · 1 trial · 2 indications

Phase 1 1
NCT04676906A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study CompoundsHealthy Volunteers
COMPLETED18 Analytics
PHASE1COMPLETED
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

The apparent elimination half-life of each of the 3 study compounds and their active metabolite after a single iv dose of each of the 3 study compounds
From time of first dosing (Day 1) until Day 64

hours

Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study compound 1EXPERIMENTALUp to 6 volunteers will receive one dose of study compound 1
Study compound 2EXPERIMENTALUp to 6 volunteers will receive one dose of study compound 2
Study compound 3EXPERIMENTALUp to 6 volunteers will receive one dose of study compound 3

Interventions

NameTypeDescription
NNC0113-6861DRUGStudy compound 1 - Each participant will receive a single intravenous (i.v) dose of \[14C\]-NNC0113-6861
NNC0113-6860DRUGStudy compound 2 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6860
NNC0113-6891DRUGStudy compound 3 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6891
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 54 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subject. * Sex : Male. * Age 18 to 54 years, inclusive, at the time of signing informed consent. * Body mass index (BMI) 18.0 to 30.0 kg/m\^2, inclusive, at the time of signing informed consent . Exclusion Criteria: * Known or suspected hypersensitivity to study prod...

Countries:Netherlands
Unlock Eligibility Criteria

Frequently asked questions about NNC0113-6861

What is NNC0113-6861?

NNC0113-6861 is an investigational small molecule being developed by Novo Nordisk for the treatment of type 2 diabetes. It is in Phase 1 clinical development and has been studied in a single completed trial involving 18 participants. It is not an approved medicine.

What is NNC0113-6861 used for in type 2 diabetes?

NNC0113-6861 is being developed as a potential treatment for type 2 diabetes. It has been evaluated in a Phase 1 study that enrolled healthy volunteers and people with type 2 diabetes. It remains investigational and is not available as a prescribed therapy.

Who makes NNC0113-6861?

NNC0113-6861 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk is the sponsor of the clinical program studying this small molecule in type 2 diabetes.

What phase is NNC0113-6861 in?

NNC0113-6861 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently listed as active. The compound is investigational and has not been approved for any indication.

What clinical trials is NNC0113-6861 in?

NNC0113-6861 has been studied in one completed Phase 1 trial, NCT04676906, titled A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds. It enrolled 18 male participants aged 18 years and older in the Netherlands and included healthy volunteers and people with type 2 diabetes.