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

• ClinicalTrials.gov Identifier: NCT06049329
• Recruitment Status: Completed
• First Posted: September 22, 2023
• Last Update Posted: March 4, 2024
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: September 11, 2023
• First Posted Date: September 22, 2023
• Last Update Posted Date: March 4, 2024
• Actual Study Start Date: September 14, 2023
• Actual Primary Completion Date: December 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 19, 2023)

• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
• Official Title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
• 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
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

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

• Condition: Obesity

Intervention

• Drug: NNC0487-0111
  Participants will get one tablet to swallow at the same time of the day.
• Drug: Placebo (NNC0487-0111)
  Participants will get one tablet to swallow at the same time of the day.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 20, 2023): 36
• Original Estimated Enrollment (submitted: September 19, 2023): 120
• Actual Study Completion Date: December 15, 2023
• Actual Primary Completion Date: December 15, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT06049329
• Other Study ID Numbers: NN9487-5022; U1111-1284-5901 ( Other Identifier: World Health Organization (WHO) )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Transparency (dept. 2834); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: March 2024