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NN9925

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Feb 28, 2017

NN9925 target and mechanism

ModalitySmall molecule

Also known as NN9925 (oral)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

NN9925 clinical trials

NN9925 · 1 trial · 3 indications

Phase 1 1
NCT01087645A Two Part Trial Investigating the Safety of NN9925 in Healthy Male SubjectsDiabetes
COMPLETED70 Analytics
PHASE1COMPLETED
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and severity of adverse events (AEs) recorded
from dosing to Day 22

Secondary Endpoints

The uptake in blood of oral NN9925
from 0 to 504 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Trial part 1EXPERIMENTAL -
Trial part 2EXPERIMENTAL -

Interventions

NameTypeDescription
NN9925 (oral)DRUGSubjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
NN9925 (i.v.)DRUGAs an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
placeboDRUGSubjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male subjects with good general health as judged by the physician * Body weight of 65-95 kg (both inclusive) * Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive) Exclusion Criteria: * Known or suspected allergy to trial product or related products * Acute infection or...

Countries:United Kingdom
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Competitive Landscape -Diabetes Complications 8 trials (matched to "Diabetes")

No competing companies are currently tracked in active development for Diabetes Complications.
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Frequently asked questions about NN9925

What is NN9925?

NN9925 is an investigational oral small molecule developed by Novo Nordisk A/S for diabetes. It is an early stage clinical candidate that has been studied in a Phase 1 trial in healthy male subjects. NN9925 is also referred to as NN9925 (oral), reflecting its oral route of administration.

What is NN9925 used for?

NN9925 is being developed for the treatment of diabetes, including type 2 diabetes mellitus. Its clinical testing to date has involved healthy male volunteers rather than patients with diabetes, so the program remains at an early investigational stage.

Who is developing NN9925?

NN9925 is being developed by Novo Nordisk A/S, the Danish pharmaceutical company that trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program evaluating the compound.

What phase is NN9925 in?

NN9925 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory authority and remains an investigational drug. One Phase 1 trial has been completed, and no active trials are currently listed for the compound.

What clinical trials has NN9925 been studied in?

NN9925 has been studied in a single Phase 1 trial, NCT01087645, titled "A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects." The trial enrolled 70 healthy male participants aged 18 years and older in the United Kingdom and has been completed.

How was the NN9925 Phase 1 trial designed?

The Phase 1 trial of NN9925, NCT01087645, was a randomized, double-blind, controlled study conducted in healthy male volunteers in the United Kingdom. It enrolled 70 participants and has been completed. The trial was designed to investigate the safety of NN9925.