Healthy VolunteersPhase 1NCT04016974
A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese
A Phase 1 study testing Oral semaglutide in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Diabetes Mellitus, Type 2
- What is being tested?
- Oral semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 26 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 2
- Being tested
- Oral semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral semaglutideDrug
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)
PlaceboDrug
Placebo tablets once daily throughout the treatment period (day 1 to 84)
| Study group | Role | What they receive |
|---|---|---|
| Oral semaglutide | Experimental | Not described Receives: Drug: Oral semaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state
h*nmol/L
Measured: 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 outcomes (12)
Cmax,sema,SS, maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state
nmol/L
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After the last dose of oral semaglutide 14 mg on day 84
Vss/Fsema, apparent volume of distribution of semaglutide at steady state
L
Measured: After the last dose of oral semaglutide 14 mg on day 84
MRTsema,SS, mean residence time of semaglutide at steady state
h
Measured: 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
Measured: After the last dose of oral semaglutide 14 mg on day 84
Change in body weight from baseline
kg
Measured: Day 1, day 85
Change in fasting plasma glucose from baseline
mmol/l
Measured: Day 1, day 85
Number of treatment-emergent adverse events
Count
Measured: 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
Measured: From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start8 Oct 2019
- Primary completion23 Jan 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016974
- Sponsor's protocol ID
- NN9924-4303
- Other IDs
- U1111-1186-6753
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2019
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 38808476
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04016974
- Acronym / sponsor ID
- NN9924-4303
- Conditions
- Healthy Volunteers, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral semaglutide | Experimental | Drug: Oral semaglutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral semaglutideSemaglutide 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) | Drug | Oral semaglutide |
| PlaceboPlacebo tablets once daily throughout the treatment period (day 1 to 84) | Drug | Placebo |
Primary outcome
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
h*nmol/L
12 secondary outcomes
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
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
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
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
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
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
MRTsema,SS, mean residence time of semaglutide at steady state
Time frame: 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
Time frame: After the last dose of oral semaglutide 14 mg on day 84
Change in body weight from baseline
Time frame: Day 1, day 85
Change in fasting plasma glucose from baseline
Time frame: Day 1, day 85
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Results publication: PubMed 38808476Xie 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral semaglutide in people with Healthy Volunteers and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.