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NNC0471-0119

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 3, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

NNC0471-0119 · 1 trial · 1 indication

Phase 1 1
NCT04655690A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes MellitusDiabetes Mellitus, Type 1
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events (AEs)
From investigational medicinal product (IMP) administration at day 1 (Visit 2) and up to 22 days post IMP administration (Visit 3)

Number of events

Secondary Endpoints

Number of hypoglycaemic episodes
0 to 24 hours after IMP administration
AUCNNC0471-0119,0-30 min/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 0-30 min and 0-t, where t is the last observed time point with insulin concentration above lower limit of quantification (LLOQ).
0 to 12 hours after IMP administration
AUCNNC0471-0119,2h-t/AUCNNC0471-0119,0-t: Ratio of the area under the serum NNC0471-0119 concentration-time curve from 2 hours to t and 0 to t, where t is the last observed time point with insulin concentration above LLOQ.
0 to 12 hours after IMP administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0471-0119EXPERIMENTALParticipants randomised to NNC0471-0119
Faster aspartACTIVE_COMPARATORParticipants randomised to faster aspart.

Interventions

NameTypeDescription
NNC0471-0119DRUGParticipants will be randomised to either of five dose levels 0.3, 0.6, 1.2, 2.4 or 3.6 of NNC0471-0119 nanomol per kilogram body weight, which will be administered as a single dose. NNC0471-0119 will be administered subcutaneously (s.c., under the skin) in fasting state.
Fast-acting insulin aspartDRUGParticipants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight, administered subcutaneously (s.c., under the skin) in fasting state.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male subject or female subject of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without...

Countries:Austria
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Frequently asked questions about NNC0471-0119

What is NNC0471-0119 used for?

NNC0471-0119 is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does NNC0471-0119 target?

NNC0471-0119 is a small molecule insulin. It is designed to work as an insulin replacement in people with Type 1 Diabetes Mellitus, helping to manage blood glucose levels.

Who makes NNC0471-0119?

NNC0471-0119 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO.

What phase is NNC0471-0119 in?

NNC0471-0119 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency.

What clinical trials is NNC0471-0119 in?

NNC0471-0119 has one completed Phase 1 trial, NCT04655690, which studied its safety and how it works in people with Type 1 Diabetes Mellitus. The trial enrolled 48 participants in Austria and was randomized, double-blind, and active-controlled.

Is NNC0471-0119 the same as insulin?

NNC0471-0119 is an insulin, specifically a small molecule insulin. It is being studied as a potential treatment for Type 1 Diabetes Mellitus, but it is not the same as other marketed insulin products.