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

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Other: Placebo (NNC0662-0419); Drug: NNC0662-0419

Study type: Interventional

Funder types: Industry

Identifiers

NCT06737536

NN9662-7694

U1111-1304-7446 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Part A: Single ascending dose (SAD)

Experimental group

Description:

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.

Treatment:

Drug: NNC0662-0419

Other: Placebo (NNC0662-0419)

Part B: Multiple ascending dose (MAD)

Experimental group

Description:

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.

Treatment:

Drug: NNC0662-0419

Other: Placebo (NNC0662-0419)