A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity

NCT07566390 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9695-8150U1111-1328-9401
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Measured as number of events.

  From time of dosing (day 1) up to day 43

Secondary Outcomes (2)

• 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

Study Arms (7)

Cohort 1 NNC0113-5840

EXPERIMENTAL

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

Drug: NNC0113-5840

Cohort 2 NNC0113-5840

EXPERIMENTAL

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

Drug: NNC0113-5840

Cohort 3 NNC0113-5840

EXPERIMENTAL

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

Drug: NNC0113-5840

Cohort 4 NNC0113-5840

EXPERIMENTAL

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

Drug: NNC0113-5840

Cohort 5 NNC0113-5840

EXPERIMENTAL

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

Drug: NNC0113-5840

Cohort 6 NNC0113-5840

EXPERIMENTAL

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

Drug: NNC0113-5840

Placebo matching NNC0113-5840

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC0113-5840 subcutaneously.

Drug: Placebo

Interventions

NNC0113-5840 DRUG

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

Cohort 1 NNC0113-5840; Cohort 2 NNC0113-5840; Cohort 3 NNC0113-5840; Cohort 4 NNC0113-5840; Cohort 5 NNC0113-5840; Cohort 6 NNC0113-5840

Placebo DRUG

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

Placebo matching NNC0113-5840

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

PAREXEL Glendale/LA EPCU

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)