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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo (NNC0487-0111); Drug: NNC0487-0111

Study type: Interventional

Funder types: Industry

Identifiers

NCT06049329

NN9487-5022

U1111-1284-5901 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

NNC0487-0111

Experimental group

Description:

Once-daily oral administration - 1 of 3 different doses

Treatment:

Drug: NNC0487-0111

Placebo

Placebo Comparator group

Description:

Once-daily oral administration - 1 of 3 different doses

Treatment:

Drug: Placebo (NNC0487-0111)