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NNC0638-0355

Phase 1

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

NNC0638-0355 · 1 trial · 2 indications

Phase 1 1
NCT06577766A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or ObesityObesity
ACTIVE NOT_RECRUITING63 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Number of treatment emergent adverse events (TEAE)
From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)

Measured as Number of events

Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)

Measured as Number of events

Secondary Endpoints

Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve
From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0638-0355EXPERIMENTALParticipants will be randomized to receive NNC0638-0355. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD).
PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B, C,D and E: Multiple ascending dose (MAD).

Interventions

NameTypeDescription
NNC0638-0355DRUGNNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo (NNC0638-0355)DRUGPlacebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites4

Key inclusion criteria * Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally ...

Countries:United StatesNetherlands
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Recent Changes (Last 90 Days)

MEDIUMAug 17, 2026NCT06577766primaryCompletionDate: changed
MEDIUMAug 17, 2026NCT06577766primaryCompletionDate: changed

Frequently asked questions about NNC0638-0355

What is NNC0638-0355 used for?

NNC0638-0355 is an investigational small molecule being developed for the treatment of obesity. It is currently being studied in people living with overweight or obesity. The drug is in Phase 1 clinical development and has not yet been approved by regulatory authorities.

Who makes NNC0638-0355?

NNC0638-0355 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for obesity.

What phase is NNC0638-0355 in?

NNC0638-0355 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is being studied in a Phase 1 trial to assess its effects in people with overweight or obesity.

What clinical trials is NNC0638-0355 in?

NNC0638-0355 is being evaluated in a Phase 1 clinical trial registered as NCT06577766. This randomized, double-blind, placebo-controlled study is investigating how the drug works in people living with overweight or obesity. The trial is active but not recruiting, with an enrollment of 63 participants across the United States and Netherlands.

How does NNC0638-0355 work?

NNC0638-0355 is a small molecule being developed for obesity. The specific molecular target or mechanism of action has not been disclosed in available information. The drug is currently in Phase 1 clinical trials to evaluate its effects in people with overweight or obesity.