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NNC0113-5840

Phase 1

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Aug 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

NNC0113-5840 · 1 trial · 2 indications

Phase 1 1
NCT07566390A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or ObesityObesity
RECRUITING48 Analytics
PHASE1RECRUITING
A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) up to day 43

Measured as number of events.

Secondary Endpoints

AUC: Area under the NNC0113-5840 plasma concentration time-curve
From pre-dose (day 1) up to day 43
Cmax: Maximum observed NNC0113-5840 plasma concentration
From pre-dose (day 1) up to day 43
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.
Cohort 2 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.
Cohort 3 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.
Cohort 4 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.
Cohort 5 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.
Cohort 6 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.
Placebo matching NNC0113-5840PLACEBO_COMPARATORParticipants will receive placebo matched to NNC0113-5840 subcutaneously.

Interventions

NameTypeDescription
NNC0113-5840DRUGNNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
PlaceboDRUGPlacebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female 2. Age 18-55 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the ...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 4, 2026NCT07566390primaryCompletionDate: changed
LOWAug 4, 2026NCT07566390primaryCompletionDate: changed

Frequently asked questions about NNC0113-5840

What is NNC0113-5840 used for?

NNC0113-5840 is an investigational small molecule being developed for the treatment of obesity and overweight. It is currently in Phase 1 clinical development, with a study recruiting participants in the United States who are 18 years and older.

Who makes NNC0113-5840?

NNC0113-5840 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 trials to evaluate the drug's effects in people with overweight or obesity.

What phase is NNC0113-5840 in?

NNC0113-5840 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 to assess its safety and how it works in the body.

What clinical trials is NNC0113-5840 in?

NNC0113-5840 is being studied in a Phase 1 clinical trial with the identifier NCT07566390. This randomized, double-blind, placebo-controlled study is investigating how the new medicine works in people with overweight or obesity, with an enrollment of 48 participants in the United States.

Is NNC0113-5840 the same as any other drug?

NNC0113-5840 is the specific name of this investigational drug candidate. No alternative names have been reported for this compound in the available clinical trial information.