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

June 1, 2026 updated by: Novo Nordisk A/S

A First in Human Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC0113-5840 in Participants With Overweight or Obesity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • PAREXEL Glendale/LA EPCU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.
Drug: NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental: Cohort 2 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.
Drug: NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental: Cohort 3 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.
Drug: NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental: Cohort 4 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.
Drug: NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental: Cohort 5 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.
Drug: NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Experimental: Cohort 6 NNC0113-5840
Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.
Drug: NNC0113-5840
NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
Placebo Comparator: Placebo matching NNC0113-5840
Participants will receive placebo matched to NNC0113-5840 subcutaneously.
Drug: Placebo
Placebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment emergent adverse events (TEAEs)
Time Frame: From time of dosing (day 1) up to day 43
Measured as number of events.
From time of dosing (day 1) up to day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC: Area under the NNC0113-5840 plasma concentration time-curve
Time Frame: From pre-dose (day 1) up to day 43
Measured as hours*nanomole per liter (h*nmol/L)
From pre-dose (day 1) up to day 43
Cmax: Maximum observed NNC0113-5840 plasma concentration
Time Frame: From pre-dose (day 1) up to day 43
Measured as nanomoles per liter (nmol/L)
From pre-dose (day 1) up to day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

November 26, 2026

Study Completion (Estimated)

November 26, 2026

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9695-8150
  • U1111-1328-9401 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on NNC0113-5840

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe