NNC0662-0419 for Obesity

Lincoln, NE

Phase 1

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 19-55 years at the time of signing the informed consent

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial is testing a new medication for overweight or obese individuals. The goal is to determine its safety, how it works in the body, and how the body processes it. Participants will receive either the

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Who is the study for?

This trial is for individuals living with overweight or obesity. Participants will be randomly assigned to receive either the new study medicine NNC0662-0419 or a placebo, which has no active ingredients. The treatment involves injections under the skin and the study spans approximately 9 months.Check my eligibility

What is being tested?

The trial is evaluating the safety and biological effects of NNC0662-0419, a new medication that cannot yet be prescribed by doctors. This first-in-human study aims to understand how this potential obesity treatment works in the body and what the body does to it.See study design

What are the potential side effects?

Since this is a first-in-human study, specific side effects are not yet known but may include reactions at injection sites, general discomfort, or other unexpected responses due to its novel nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 55 years old.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from pre-dose on day 1 until completion of the end of study visit (up to 9 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose on day 1 until completion of the end of study visit (up to 9 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Number of treatment emergent adverse events (TEAE)

Part B: Number of treatment-emergent adverse events (TEAE)

Secondary study objectives

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

Part A: Cmax; the maximum plasma concentration of NNC0662-0419

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

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Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Multiple ascending dose (MAD)Experimental Treatment2 Interventions

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.

Group II: Part A: Single ascending dose (SAD)Experimental Treatment2 Interventions

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.

0 / 1Eligibility criteria met