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

NCT ID: NCT04016974

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2021-02-26

Brief Summary

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.

Conditions

Healthy Volunteers; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral semaglutide

Group Type: EXPERIMENTAL

Oral semaglutide

Intervention Type: DRUG

Semaglutide tablets once daily as follows: 3 mg for the first treatment period (day 1-28), followed by 7 mg in the second treatment period (day 29-56), followed by 14 mg in the third treatment period (day 57-84)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets once daily throughout the treatment period (day 1 to 84)

Interventions

Oral semaglutide

Semaglutide tablets once daily as follows: 3 mg for the first treatment period (day 1-28), followed by 7 mg in the second treatment period (day 29-56), followed by 14 mg in the third treatment period (day 57-84)

Intervention Type: DRUG

Placebo

Placebo tablets once daily throughout the treatment period (day 1 to 84)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Beijing Hospital-phase I

Beijing, Beijing Municipality, China

Countries

China

References

Xie P, Abildlund MT, Baekdal TA, He X, Lyauk YK, Patted URH, Ning Z, Shi A. A phase 1, randomized, double-blind, placebo-controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects. Diabetes Obes Metab. 2024 Aug;26(8):3068-3077. doi: 10.1111/dom.15624. Epub 2024 May 29.

Reference Type: RESULT

PMID: 38808476 (View on PubMed)

Other Identifiers

U1111-1186-6753

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4303

Identifier Type: -

Identifier Source: org_study_id