Clinical trial NCT06737536: A First-in-human Research Study on How NNC0662-0419 Works in People Living With Overweight or Obesity
Official title: A Single- and Multiple-ascending Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of NNC0662-0419 in Participants Living With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part A: Number of treatment emergent adverse events (TEAE)
timeFrame: From timing of dosing on day 1 until completion of the end of study visit (up to 6 weeks)
measure: Part B: Number of treatment-emergent adverse events (TEAE)
timeFrame: From timing of dosing on day 1 until completion of the end of study visit (up to 9 weeks)
Secondary outcomes:
measure: Part A: AUC; the area under the NNC0662-0419 plasma concentration-time curve
timeFrame: From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)
measure: Part A: Cmax; the maximum plasma concentration of NNC0662-0419
timeFrame: From pre-dose on day 1 until completion of the end of study visit (up to 6 weeks)
measure: Part B: AUC; the area under the NNC0662-0419 plasma concentration-time curve
timeFrame: From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)
measure: Part B: Cmax; the maximum plasma concentration of NNC0662-0419
timeFrame: From pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion, Lincoln
state: Nebraska
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: