A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity

Phase 1

Recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: Placebo (NNC0638-0355); Drug: NNC0638-0355

• Registration Number: NCT06577766
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-29
• Study Start: 2024-09-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-09-18
• Study Completion: 2025-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (NNC0638-0355)	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).
NNC0638-0355	NNC0638-0355	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).

Primary Outcome Measures

Name	Time	Method
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 : 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 Outcome Measures

Name	Time	Method
Part B,C,D: 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)	Measured in hour\*nano mole per litre (h\*nmol/L)
Part B,C,D: Cmax; maximum observed NNC0638-0355 plasma concentration	From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)	Measured in nano mole per litre (nmol/L)
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)	Measured in hours\*nano mole per litre (h\*nmol/L)
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration	From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)	Measured in nano mole per litre (nmol/L)
Part A: t½; terminal half-life of NNC0638-0355	From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)	Measured in hours (h)

Trial Locations

Locations (1)

ICON; 🇺🇸 San Antonio, Texas, United States