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NNC0385

Phase 1

High Cholesterol | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Jul 12, 2024

NNC0385 target and mechanism

ModalitySmall molecule

Also known as NNC0385-0434 G

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

NNC0385 clinical trials

NNC0385 · 1 trial · 1 indication

Phase 1 1
NCT05333107A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IIHealthy Volunteers; High Cholesterol
COMPLETED152 Analytics
PHASE1COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Healthy Volunteers; High CholesterolUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
From 0 to 24 hours after dose administration on visit 2, day 10

Measured in h \* nmol/L

Secondary Endpoints

Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434
From 0 to 24 hours after dose administration on visit 2, day 10
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434
From 0 to 24 hours after dose administration on visit 2, day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
Sequence 2EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
Sequence 3EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
Sequence 4EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
Sequence 5EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
Sequence 6EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Interventions

NameTypeDescription
NNC0385-0434 GDRUGParticipants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
NNC0385-0434 FDRUGParticipants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
NNC0385-0434 BDRUGParticipants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
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Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male * Aged 18-64 years (both inclusive) at the time of signing informed consent * Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive) * Considered to be generally healthy based on the medical history, physical examination, and the results of vital...

Countries:United States
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Frequently asked questions about NNC0385

What is NNC0385?

NNC0385 is an investigational small molecule developed by Novo Nordisk A/S for high cholesterol. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not approved for any use, and it remains an experimental oral therapy rather than an available treatment.

What is NNC0385 used for in high cholesterol?

NNC0385 is being developed for high cholesterol, a metabolic condition. The only completed study enrolled healthy male volunteers alongside a high cholesterol condition listing, so the program is still at an early research stage. No approved use for lowering cholesterol has been established for NNC0385.

Who makes NNC0385?

NNC0385 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 Phase 1 study of the compound. No partner or co-development arrangement for NNC0385 is part of the public program record.

What phase is NNC0385 in?

NNC0385 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it is investigational, NNC0385 is not FDA approved, and it has not moved beyond early-stage testing in humans.

What clinical trials is NNC0385 in?

NNC0385 has been studied in one completed Phase 1 trial, NCT05333107, titled a research study looking at new protein-based tablets in healthy men, oral formulation II. It enrolled 152 participants in the United States, was randomized and controlled, and included males aged 18 years and older.

Is NNC0385 the same as NNC0385-0434 G?

Yes, NNC0385-0434 G is an alternative designation for NNC0385, the investigational small molecule from Novo Nordisk A/S being studied for high cholesterol. Readers searching either name are looking at the same Phase 1 compound and the same completed trial, NCT05333107.