Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04016974Other idNN9924-4303Other idU1111-1186-6753

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 32 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 8 Oct 2019
Primary completion: 23 Jan 2021
Completion: 26 Feb 2021
First posted: 12 Jul 2019
Last update posted: 12 Jul 2024
Conditions: Healthy Volunteers · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2019202020212022

Ph 1
A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese
NCT04016974
8 Oct 2019 to 26 Feb 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Oral semaglutideDrug
PlaceboDrug

Arms2

Experimental
Oral semaglutide
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state
Time frame · 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
Registry description
h\*nmol/L

Secondary outcomes(12)

Cmax,sema,SS, maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state
Time frame · 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
Registry description
nmol/L
tmax,sema,SS, time to maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state
Time frame · 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
Registry description
h
CL/Fsema,SS, total apparent clearance of semaglutide at steady state
Time frame · 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
Registry description
L/h
Ctrough,sema,SS, trough semaglutide plasma concentration at steady state
Time frame · 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
Registry description
nmol/L
t½,sema,SS, terminal half-life of semaglutide at steady state
Time frame · After the last dose of oral semaglutide 14 mg on day 84
Registry description
h
Vss/Fsema, apparent volume of distribution of semaglutide at steady state
Time frame · After the last dose of oral semaglutide 14 mg on day 84
Registry description
L
MRTsema,SS, mean residence time of semaglutide at steady state
Time frame · After the last dose of oral semaglutide 14 mg on day 84
Registry description
h
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
Time frame · After the last dose of oral semaglutide 14 mg on day 84
Registry description
Index value
Change in body weight from baseline
Time frame · Day 1, day 85
Registry description
kg
Change in fasting plasma glucose from baseline
Time frame · Day 1, day 85
Registry description
mmol/l
Number of treatment-emergent adverse events
Time frame · From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
Registry description
Count
Number of treatment-emergent hypoglycaemic episodes
Time frame · From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
Registry description
Count

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

10 results

A phase 1, randomized, double-blind, placebo-controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects.

Xie et al. 2024Diabetes, obesity & metabolismcited by 8

PMID 38808476DOI 10.1111/dom.15624PUB-38808476

Full text at the publisher10 results

Publisher page See results (10)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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