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

A Multiple-dose, Single-centre, Randomised, Double-blind, Placebo-controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Chinese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Healthy Volunteers
• Intervention / Treatment: Drug: Oral semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo tablets once daily throughout the treatment period (day 1 to 84)
EXPERIMENTAL: Oral semaglutide	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state	h*nmol/L	After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,sema,SS, maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state	nmol/L	After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
tmax,sema,SS, time to maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state	h	After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
CL/Fsema,SS, total apparent clearance of semaglutide at steady state	L/h	After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84
Ctrough,sema,SS, trough semaglutide plasma concentration at steady state	nmol/L	After the last 3 daily doses of oral semaglutide administration at 3, 7 and 14 mg dose levels on day 27-29, 55-57 and 83-85
t½,sema,SS, terminal half-life of semaglutide at steady state	h	After the last dose of oral semaglutide 14 mg on day 84
Vss/Fsema, apparent volume of distribution of semaglutide at steady state	L	After the last dose of oral semaglutide 14 mg on day 84
MRTsema,SS, mean residence time of semaglutide at steady state	h	After the last dose of oral semaglutide 14 mg on day 84
Rtheor,sema,SS, theoretical accumulation index, which is defined as [1/(1-Exp (-λZ,sema,SS*24h))], where λZ,sema,SS=log(2)/t½,sema,SS	Index value	After the last dose of oral semaglutide 14 mg on day 84
Change in body weight from baseline	kg	Day 1, day 85
Change in fasting plasma glucose from baseline	mmol/l	Day 1, day 85
Number of treatment-emergent adverse events	Count	From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
Number of treatment-emergent hypoglycaemic episodes	Count	From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2019
• Primary Completion (ACTUAL): January 23, 2021
• Study Completion (ACTUAL): February 26, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9924-4303; U1111-1186-6753 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No