A Research Study of How a New Medicine Called Amycretin,... | NCT06049329

Studies
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity

NCT06049329

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Mar 5, 2025Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Obesity

Interventions

NNC0487-0111
Placebo (NNC0487-0111)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1284-5901	Other Identifier	World Health Organization (WHO)

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2023Actual

Primary Completion Date

Dec 15, 2023Actual

Completion Date

Dec 15, 2023Actual

First Submitted Date

Sep 11, 2023

First Submission Date that Met QC Criteria

Sep 19, 2023

First Posted Date

Sep 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2025

Last Update Posted Date

Mar 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NNC0487-0111	Experimental	Once-daily oral administration - 1 of 3 different doses	Drug: NNC0487-0111
Placebo	Placebo Comparator	Once-daily oral administration - 1 of 3 different doses	Drug: Placebo (NNC0487-0111)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NNC0487-0111	Drug	Participants will get one tablet to swallow at the same time of the day.	NNC0487-0111

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of treatment emergent adverse events (TEAE)	Number of events	From pre-dose on Day 1 until completion of the end of study visit Day 31

Secondary Outcomes

Measure	Description	Time Frame
AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose	h*nmol/L	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key inclusion criteria

Male with both parents of Japanese descent
Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Body weight equal to or greater than 65.0 kg
Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Key exclusion criteria

Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Transparency (dept. 2834)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hakata Clinic		Fukuoka		812-0025	Japan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://novonordisk-trials.com

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided