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NNC0472-0147

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 28, 2022

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

Clinical trial landscape

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 used for?

NNC0472-0147 is an investigational small molecule being developed by Novo Nordisk for metabolic conditions. It is currently in Phase 1 clinical development, studied in healthy volunteers and people with type 2 diabetes. The drug is not approved and remains in clinical trials.

Who makes NNC0472-0147?

NNC0472-0147 is developed by Novo Nordisk A/S, a pharmaceutical company traded on the NYSE under the ticker NVO. The company is conducting clinical trials to evaluate the safety of this investigational small molecule in healthy volunteers and individuals with type 2 diabetes.

What phase is NNC0472-0147 in?

NNC0472-0147 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It is not approved by regulatory authorities and is still being studied for safety in healthy volunteers and people with type 2 diabetes.

What clinical trials is NNC0472-0147 in?

NNC0472-0147 has 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.

Is NNC0472-0147 FDA approved?

NNC0472-0147 is not FDA approved. It is an investigational drug in Phase 1 clinical development. A completed Phase 1 trial assessed its safety in healthy volunteers and people with type 2 diabetes, but the drug has not received regulatory approval for any use.