A research study of a new medicine NNC0519-0130 in Japanese and non-Japanese men

JRCT ID: jRCT2071230015

Registered date:26/05/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 15/05/2023
• Target sample size: 70
• Study type: Interventional

Intervention(s)

<Oral study part>
- 28-day screening period.
- Dose escalation every three weeks is applied and four dose levels (NNC0519-0130 5 mg, 12 mg, 25 mg, 50 mg) or placebo will be tested.
- 24 participants within each race group will receive the trial product by once-daily oral dosing for total 12 weeks.
- 3-week follow-up period.

<S.C. study part>
- 28-day screening period
- Dose escalation every three weeks is applied and five dose levels (NNC0519-0130 0.3 mg,0.6 mg,0.9 mg,1.2 mg,1.8 mg,3.0 mg) or placebo will be tested.
- 11 participants within each race group will receive the trial product by once daily s.c. administration for total 15 weeks.
- 3-week follow-up period

Outcome(s)

Primary Outcome

-Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
- Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period
- Terminal half-life of NNC0519-0130 after the last dose

• Secondary Outcome: Number of treatment emergent adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

- Body mass index (BMI) between 23.0 kg/m2 and 39.9 kg/m2 (both inclusive) at screening with a minimum weight of 50 kg. Overweight should be due to excess adipose tissue, as judged by the investigator.
- 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.

Exclude criteria

- Any disorder, which in the investigator opinion might jeopardise safety of participant or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, GI, or endocrinological conditions.
- HbA1c >= 6.5 % (48 mmol/mol) at screening.
-Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.

Related Information

• Primary Sponsor: Tsukasaki Nobuaki