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NNC0165-1875

Phase 1

Obesity and Overweight | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 6, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

NNC0165-1875 · 1 trial · 1 indication

Phase 1 1
NCT03707990A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or ObeseObesity and Overweight
COMPLETED88 Analytics
PHASE1COMPLETED
A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese
Obesity and OverweightUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
Day 1-36

Count of adverse events.

Secondary Endpoints

AUC0-∞,1875,SD; the area under the NNC0165-1875 plasma concentration-time curve from time 0 to infinity after a single s.c. dose
1-36 days
Cmax,1875,SD; the maximum plasma concentration of NNC0165-1875 after a single s.c. dose
1-36 days
AUC0-∞,sema,SD; the area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single s.c. dose
1-36 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0165-1875EXPERIMENTALParticipants will receive NNC0165-1875 alone in cohorts 1-5 (part 1) and NNC0165-1875 along with semaglutide in cohorts 6-11 (part 2).
PlaceboPLACEBO_COMPARATORParticipants will receive placebo alone in cohorts 1-5 (part 1) and placebo along with semaglutide in cohorts 6-11 (part 2).

Interventions

NameTypeDescription
NNC0165-1875DRUGParticipants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.
Placebo (NNC0165-1875)DRUGParticipants will receive a single dose of s.c. placebo injection.
SemaglutideDRUGParticipants will receive a single dose of s.c. semaglutide 0.25 mg injection.
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Eligibility Criteria

SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator * Body weight greater than or ...

Countries:United States
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Frequently asked questions about NNC0165-1875

What is NNC0165-1875 used for?

NNC0165-1875 is an investigational small molecule being developed for obesity and overweight. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in people who are overweight or obese, with the goal of addressing these metabolic conditions.

Who makes NNC0165-1875?

NNC0165-1875 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research on this investigational drug for the treatment of obesity and overweight.

What phase is NNC0165-1875 in?

NNC0165-1875 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial for this drug has been completed.

What clinical trials is NNC0165-1875 in?

NNC0165-1875 has been studied in one clinical trial with the identifier NCT03707990. This Phase 1 trial, titled 'A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese,' was completed in the United States and enrolled 88 male participants.

How does NNC0165-1875 work?

The specific molecular target of NNC0165-1875 has not been disclosed in available information. As a small molecule, it is being investigated for its potential effects in treating obesity and overweight, but its exact mechanism of action is not publicly detailed.