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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06049329
Recruitment Status : Completed
First Posted : September 22, 2023
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: NNC0487-0111 Drug: Placebo (NNC0487-0111) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
Actual Study Start Date : September 14, 2023
Actual Primary Completion Date : December 15, 2023
Actual Study Completion Date : December 15, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: NNC0487-0111
Once-daily oral administration - 1 of 3 different doses
 Drug: NNC0487-0111
Participants will get one tablet to swallow at the same time of the day.
Placebo Comparator: Placebo
Once-daily oral administration - 1 of 3 different doses
 Drug: Placebo (NNC0487-0111)
Participants will get one tablet to swallow at the same time of the day.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose [ Time Frame: From pre-dose on Day 10 until Day 11 (24 hours post-dose) ]
    h*nmol/L

  2. Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose [ Time Frame: From pre-dose on Day 10 until completion of the end of study visit Day 31 ]
    nmol/L

  3. tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose [ Time Frame: From pre-dose on Day 10 until completion of the end of study visit Day 31 ]
    hour


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049329


Locations
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Japan
Hakata Clinic
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 2834) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT06049329    
Other Study ID Numbers: NN9487-5022
U1111-1284-5901 ( Other Identifier: World Health Organization (WHO) )
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight