A First-in-human Research Study on How NNC0662-0419 Works in People Living With Overweight or Obesity

A Single- and Multiple-ascending Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of NNC0662-0419 in Participants Living With Overweight or Obesity

This study is testing a new study medicine which may be used to treat people living with overweight or obesity. The purpose of the study is to see if the new study medicine is safe, how it works in human body and what human body does to the study medicine. Participants will either get the study medicine NNC0662-0419 or placebo (a "dummy" medicine without any active ingredients) given by study staff as an injection under participants skin. Which treatment participants will get is decided by chance. NNC0662-0419 is a new medicine, which cannot be prescribed by doctors. This is the first time the medicine is being given to humans. The study will last for about 9 months.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0662-0419; Other: Placebo (NNC0662-0419)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion, Lincoln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female (sex at birth)
• Aged 19-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (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, as judged by the investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the corrected QT interval by Fridericia (QTcF) calculation over 450 ms (females) or 430 ms (males), or any other clinically significant abnormal ECG results as judged by the investigator, at screening.
• Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
• Calcitonin >= 50 nanogram per liter (ng/L) at screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Single ascending dose (SAD); Participants will receive a single dose of any of the five different dose levels of NNC0662-0419 or matching placebo in a sequential manner with the dose increasing between cohorts.	Drug: NNC0662-0419; Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.; Other: Placebo (NNC0662-0419); Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.
Experimental: Part B: Multiple ascending dose (MAD); Participants will receive NNC0662-0419 once-weekly for 4 weeks at any of the four different dose levels or matching placebo in a sequential manner with the dose increasing between cohorts.	Drug: NNC0662-0419; Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.; Other: Placebo (NNC0662-0419); Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Number of treatment emergent adverse events (TEAE)	Number of events	From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)
Part B: Number of treatment-emergent adverse events (TEAE)	Number of events	From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve	measured in hour*nanomoles per liter (h*nmol/L)	From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)
Part A: Cmax; the maximum plasma concentration of NNC0662-0419	measured in nanomoles per liter(nmol/L)	From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)
Part B: AUC; the area under the NNC0662-0419 plasma concentration-time curve	measured in h*nmol/L	From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)
Part B: Cmax; the maximum plasma concentration of NNC0662-0419	measured in nmol/L	From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Actual): July 26, 2025
• Study Completion (Actual): July 26, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: NN9662-7694; U1111-1304-7446 (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