A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: Oral semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04016974

U1111-1186-6753 (Other Identifier)

NN9924-4303

Details and patient eligibility

About

This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. It will also look at if the medicine is safe and the body can accept it. The new medicine is planned to treat diabetes. The aim of the study is to see how semaglutide tablets work in healthy people who are Chinese. Participants will either get oral semaglutide tablets or placebo (dummy) tablets - which treatment is decided by chance. The tablet form of semaglutide is a new medicine that cannot be prescribed. Doctors can prescribe semaglutide as an injection only. It is for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 12 weeks (84 days). Participants will get 1 tablet a day to take with up to half a glass of water (maximum 120 mL). Participants must take the tablet first thing in the morning on an empty stomach (water is allowed until 2 hours before taking the tablet). After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After 30 minutes, they can have their first meal of the day and take any other medicines they may need, such as birth control tablets, routine vitamins and use of paracetamol at times.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
Body weight equal to or above 54.0 kg
Body mass index (BMI) between 20.0 and 24.9 kg/m^2 (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
History of pancreatitis (acute or chronic) as declared by the subject.
Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the subject.
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) as declared by the subject.
History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) as declared by the subject.
Smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day).
Unable or unwilling to refrain from smoking and use of nicotine substitute products during the inpatient periods, as judged by the investigator.
Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening.