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NNC0638-0355 for Obesity

Phase 1
Waitlist Available
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
Key inclusion criteria
* Male or female.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first nnc0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
Awards & highlights

Summary

The study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in your body, and what your body does to the study medicine. Participants will either get the study medicine or placebo (a "dummy medicine" similar to the study medicine but without active ingredients) given as an injection under your skin. Which treatment the participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.

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

Timeline

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).

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Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,528 Previous Clinical Trials
2,420,660 Total Patients Enrolled
145 Trials studying Obesity
132,486 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
113 Previous Clinical Trials
141,469 Total Patients Enrolled
31 Trials studying Obesity
49,856 Patients Enrolled for Obesity
~59 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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