NNC0638-0355 for Obesity

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

Age 18-55 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 first nnc0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

Summary

This trial is testing a new medicine for overweight or obese individuals. The goal is to determine the safety and effectiveness of the medicine. Participants will receive either the study medicine or a placebo through injections under the

Who is the study for?

This trial is for people who are living with overweight or obesity. Participants will be chosen randomly to receive either the new medicine NNC0638-0355 or a placebo, both administered as injections under the skin.

What is being tested?

The study is evaluating NNC0638-0355, a potential new medication that cannot yet be prescribed by doctors. It aims to determine its safety and how it affects and is processed by the body of individuals with overweight or obesity.

What are the potential side effects?

Since this is an investigational study, specific side effects of NNC0638-0355 are not listed but may include reactions at the injection site, general discomfort, or other unexpected symptoms related to treatment.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first nnc0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first nnc0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first nnc0638-0355 administration (day 1) to completionof the end of study visit (20 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,C,D : Number of treatment emergent adverse events (TEAE)

Secondary study objectives

Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve

Part A: Cmax; maximum observed NNC0638-0355 plasma concentration

Part A: t½; terminal half-life of NNC0638-0355

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NNC0638-0355Experimental Treatment1 Intervention

Participants will be randomized to receive NNC0638-0355. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD) Part B, C and D: Multiple ascending dose (MAD).

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive Placebo. The study will be conducted in 4 parts. Part A: Single ascending dose (SAD). Part B,C and D: Multiple ascending dose (MAD).

0 / 1Eligibility criteria met