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NNC0174 0833

Phase 1

Overweight and Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 7, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

NNC0174 0833 · 1 trial · 1 indication

Phase 1 1
NCT05254158A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With ObesityOverweight and Obesity
COMPLETED24 Analytics
PHASE1COMPLETED
A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity
Overweight and ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (Day 1) to Visit 7 (Day 36)

measured in h·nmol/L

Secondary Endpoints

AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose
From pre-dose (Day 1) to Visit 3 (Day 8)
Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma
From pre-dose (Day 1) to Visit 7 (Day 36)
tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833
From pre-dose (Day 1) to Visit 7 (Day 36)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0174 0833 1.8 mgEXPERIMENTALEach participant will receive one single dose of NNC0174 0833
NNC0174 0833 0.9 mgEXPERIMENTALEach participant will receive one single dose of NNC0174 0833
NNC0174 0833 0.3 mgEXPERIMENTALEach participant will receive one single dose of NNC0174 0833

Interventions

NameTypeDescription
NNC0174 0833DRUGParticipants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key inclusion criteria * Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Body weight between 60.0 and 110.0 kg (both inclusive) at screening. Key exclusion criteri...

Countries:China
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Frequently asked questions about NNC0174 0833

What is NNC0174-0833 used for?

NNC0174-0833 is an investigational small molecule being developed for the treatment of overweight and obesity, as well as related metabolism and nutrition disorders. It is intended for use in people who are overweight or obese, and clinical studies have included participants with these conditions.

Who makes NNC0174-0833?

NNC0174-0833 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 safety and efficacy of this investigational drug for weight management.

What phase is NNC0174-0833 in?

NNC0174-0833 is in clinical development, with trials completed in Phase 1 and Phase 2. The most advanced study was a Phase 2 trial, which has been completed. The drug is not yet approved and remains investigational, requiring further studies to establish its safety and effectiveness.

What clinical trials is NNC0174-0833 in?

NNC0174-0833 has been studied in several completed clinical trials, including NCT02300844, a Phase 1 single-dose study in healthy males; NCT03856047, a Phase 2 efficacy study in overweight or obese individuals; NCT04074174, a drug interaction study with oral contraceptives; and NCT04209049, a pharmacokinetic study in people with normal and impaired kidney function.

Is NNC0174-0833 the same as NNC0174-0833?

NNC0174-0833 is the drug name used in clinical trial registrations, with no alternative names provided in the available data. It is consistently referred to by this identifier across all studies, including those listed on ClinicalTrials.gov.