Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity

Novo Nordisk A/S1 site in 1 country36 target enrollmentSeptember 14, 2023

ConditionsObesity

InterventionsNNC0487-0111 Placebo (NNC0487-0111)

DrugsNNC0487-0111 Placebo (NNC0487-0111)

Overview

Phase: Phase 1
Intervention: NNC0487-0111
Conditions: Obesity
Sponsor: Novo Nordisk A/S
Enrollment: 36
Locations: 1
Primary Endpoint: Number of treatment emergent adverse events (TEAE)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.

Registry

clinicaltrials.gov

Start Date

September 14, 2023

End Date

December 15, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

NNC0487-0111

Once-daily oral administration - 1 of 3 different doses

Intervention: NNC0487-0111

Placebo

Once-daily oral administration - 1 of 3 different doses

Intervention: Placebo (NNC0487-0111)

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (TEAE)

Time Frame: From pre-dose on Day 1 until completion of the end of study visit Day 31

Number of events

Secondary Outcomes

AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose(From pre-dose on Day 10 until Day 11 (24 hours post-dose))
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose(From pre-dose on Day 10 until completion of the end of study visit Day 31)
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose(From pre-dose on Day 10 until completion of the end of study visit Day 31)