Recruiting
Phase 1

NNC0113-5840

Sponsor:

Novo Nordisk A/S

Code:

NCT07566390

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

NNC0113-5840

Placebo

Study Details

Brief summary:

The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.

Conditions

Obesity

Overweight

Study ID

NCT07566390

Start date

May 1, 2026

Status verified date

Sep, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 investigator.
4. Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit and visit 2, day -1, as judged by the investigator.

Exclusion Criteria:

1. Known or suspected hypersensitivity to study intervention(s) or related products.
2. Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) \[48 millimole per mole (mmol/mol)\] at screening.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 NNC0113-5840

Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.

experimental: Cohort 2 NNC0113-5840

Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.

experimental: Cohort 3 NNC0113-5840

Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.

experimental: Cohort 4 NNC0113-5840

Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.

experimental: Cohort 5 NNC0113-5840

Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.

experimental: Cohort 6 NNC0113-5840

Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.

placebo comparator: Placebo matching NNC0113-5840

Participants will receive placebo matched to NNC0113-5840 subcutaneously.

Interventions

NNC0113-5840

NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.

Placebo

Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.

Primary outcome measure

  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of dosing (day 1) up to day 43 ]

Central Contacts and Locations

Locations

PAREXEL Glendale/LA EPCU

Recruiting

Glendale, California, United States, 91206

PAREXEL Intl - EPCU-Baltimore

Recruiting

Baltimore, Maryland, United States, 21225

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-09.