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

NCT06737536 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9662-7694U1111-1304-7446
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve

  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

  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

  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

  From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

Study Arms (2)

Part A: Single ascending dose (SAD)

EXPERIMENTAL

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; Other: Placebo (NNC0662-0419)

Part B: Multiple ascending dose (MAD)

EXPERIMENTAL

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; Other: Placebo (NNC0662-0419)

Interventions

NNC0662-0419 DRUG

Participants will receive NNC0662-0419 subcutaneous (s.c.) once weekly.

Part A: Single ascending dose (SAD); Part B: Multiple ascending dose (MAD)

Placebo (NNC0662-0419) OTHER

Participants will receive placebo matched to NNC0662-0419 s.c. once weekly.

Part A: Single ascending dose (SAD); Part B: Multiple ascending dose (MAD)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• nd 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Celerion, Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: December 18, 2024
• Primary Completion: July 26, 2025
• Study Completion: July 26, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)