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NNC0471-0119 H

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Sep 10, 2026

NNC0471-0119 H development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment108

FDA Designations

No designations recorded

NNC0471-0119 H clinical trials

NNC0471-0119 H · 2 trials · 2 indications

Phase 1 2
NCT07068295A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin PumpDiabetes Mellitus, Type 2
COMPLETED65 Analytics
NCT06809621A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin PumpDiabetes Mellitus, Type 1
COMPLETED43 Analytics
PHASE1COMPLETED
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour
0 to 1 hour after bolus infusion

Measured in milligram per kilogram (mg/kg).

Secondary Endpoints

AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t
0 to 11 hours after bolus infusion
AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basal-corrected): Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t
0 to 11 hours after bolus infusion
GIR (max,basal-corrected): Maximum observed basal-corrected GIR
0 to 11 hours after bolus infusion
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0471-0119 H then Insulin AspartEXPERIMENTALParticipants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
Insulin Aspart then NNC0471-0119 HACTIVE_COMPARATORParticipants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.

Interventions

NameTypeDescription
NNC0471-0119 HDRUGNNC0471-0119 H will be administered subcutaneously.
Insulin AspartDRUGInsulin aspart will be administered subcutaneously.
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Eligibility Criteria

Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female (sex at birth). * Age 18-69 years (both inclusive) at the time of signing the informed consent. * Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening. * Treated with any injectable insulin, except once-weekly insulin, ≥ 18...

Countries:Germany
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Recent Changes (Last 90 Days)

MEDIUMOct 11, 2026NCT06809621TRIAL_REMOVED: changed
MEDIUMOct 11, 2026NCT06809621TRIAL_REMOVED: changed
MEDIUMOct 11, 2026NCT06809621TRIAL_REMOVED: changed
MEDIUMOct 11, 2026NCT06809621TRIAL_REMOVED: changed

Frequently asked questions about NNC0471-0119 H

What is NNC0471-0119 H used for?

NNC0471-0119 H is an investigational small molecule insulin being developed for the treatment of Type 1 and Type 2 diabetes mellitus. It is administered via an insulin pump. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes NNC0471-0119 H?

NNC0471-0119 H is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's effects in participants with Type 1 and Type 2 diabetes.

What phase is NNC0471-0119 H in?

NNC0471-0119 H is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in Type 1 diabetes and one in Type 2 diabetes. The drug is investigational and has not received FDA approval.

What clinical trials is NNC0471-0119 H in?

NNC0471-0119 H has been studied in two completed Phase 1 trials. NCT06809621 tested the drug in 43 participants with Type 1 diabetes in Germany. NCT07068295 tested it in 65 participants with Type 2 diabetes in Germany. Both trials evaluated the drug when given by an insulin pump.

How does NNC0471-0119 H work?

NNC0471-0119 H is an insulin analog designed to regulate blood glucose levels in people with diabetes. As a small molecule insulin, it is intended to be delivered continuously via an insulin pump to mimic the body's natural insulin secretion and control blood sugar.