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NNC0472-0147

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Sep 28, 2022

NNC0472-0147 development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

NNC0472-0147 clinical trials

NNC0472-0147 · 1 trial · 2 indications

Phase 1 1
NCT04262661A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 DiabetesHealthy Volunteers
COMPLETED36 Analytics
PHASE1COMPLETED
A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of treatment emergent adverse events
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)

Number of events

Part 2: Number of treatment emergent adverse events
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)

Number of events

Secondary Endpoints

Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of severe hypoglycaemic episodes (level 3)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0472-0147 Part 1EXPERIMENTALPart 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147.
Placebo Part 1PLACEBO_COMPARATORPart 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo.
NNC0472-0147 Part 2EXPERIMENTALPart 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days
Insulin glargine Part 2ACTIVE_COMPARATORPart 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days.

Interventions

NameTypeDescription
NNC0472-0147DRUGPart 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.
insulin glargineDRUGPart 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.
Placebo (NNC0472-0147)DRUGPart 1: A single dose of placebo, dose increased in each cohort.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Part 1: * Male * Aged 18-55 years (both inclusive) at the time of signing nformed consent. Part 2: * Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bila...

Countries:Germany
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Frequently asked questions about NNC0472-0147

What is NNC0472-0147?

NNC0472-0147 is an investigational small molecule being developed by Novo Nordisk A/S for the treatment of type 2 diabetes mellitus. It is in Phase 1 clinical development and has been studied in a single completed trial that enrolled 36 participants, including healthy volunteers and people with type 2 diabetes.

What is NNC0472-0147 used for in type 2 diabetes?

NNC0472-0147 is being evaluated as a potential treatment for type 2 diabetes mellitus. It is an investigational therapy and has not been approved for any indication. The completed Phase 1 trial included people with type 2 diabetes alongside healthy volunteers to assess the drug in both populations.

Who makes NNC0472-0147?

NNC0472-0147 is developed by Novo Nordisk A/S, a pharmaceutical company traded under the ticker NVO. Novo Nordisk is the sponsor of the Phase 1 clinical trial evaluating the compound in healthy volunteers and people with type 2 diabetes.

What phase is NNC0472-0147 in?

NNC0472-0147 is in Phase 1 clinical development. It is an investigational small molecule and is not approved for any indication. One Phase 1 trial has been completed, and no active trials are currently listed for this compound.

What clinical trials is NNC0472-0147 in?

NNC0472-0147 has been studied in one completed Phase 1 trial, NCT04262661, titled a study to look at how safe NNC0472-0147 is in healthy people and in people with type 2 diabetes. The trial enrolled 36 participants in Germany and was randomized, double-blind, and placebo-controlled.