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

Phase 1

Not yet recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: NNC0662-0419; Other: Placebo (NNC0662-0419)

• Registration Number: NCT06737536
• Lead Sponsor: Novo Nordisk A/S

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...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study Start: 2024-12-16
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-06-19
• Study Completion: 2025-07-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

• Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
• Amylase greater than or equal to (>=) 2 times upper limit of normal at screening
• Lipase greater than or equal to (>=) times upper limit of normal at screening
• Calcitonin greater than or equal to (>=) 50 nanogram per liter (ng/L) at screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: Single ascending dose (SAD)	NNC0662-0419	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.
Part A: Single ascending dose (SAD)	Placebo (NNC0662-0419)	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.
Part B: Multiple ascending dose (MAD)	NNC0662-0419	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.
Part B: Multiple ascending dose (MAD)	Placebo (NNC0662-0419)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	measured in hour\*nanomoles per liter (h\*nmol/L)
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)	measured in nanomoles per liter(nmol/L)
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)	measured in h\*nmol/L
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)	measured in nmol/L

Trial Locations

Locations (1)

Celerion, Lincoln; 🇺🇸 Lincoln, Nebraska, United States