DiabetesPhase 1NCT03288740
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
A Phase 1 study testing Semaglutide 0.5 mg and Semaglutide 1.0 mg in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
Trial summary
The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide 0.5 mg and Semaglutide 1.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2017to 7 Aug 2018
- 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
- Healthy male and female Chinese subjects
- Age between 18 to 55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20 and 24.9 kg/sqm (both inclusive)
- Body weight greater than or equal to 54.0 kg
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic products (including routine or non-routine vitamins or herbal products) or topical medicinal products (except paracetamol and oral contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (randomisation)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of pancreatitis (acute or chronic)
- Calcitonin greater than or equal to 50 ng/L
- Blood donation, surgery or trauma with significant blood loss (400 mL) within the last 12 weeks prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. The total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Semaglutide 0.5 mg, Placebo (semaglutide 0.5 mg), Semaglutide 1.0 mg, Placebo (semaglutide 1.0 mg)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 0.5 mgDrug
A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Placebo (semaglutide 0.5 mg)Drug
A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Semaglutide 1.0 mgDrug
A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Placebo (semaglutide 1.0 mg)Drug
A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 0.5 mg | Experimental | Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide. Receives: Drug: Semaglutide 0.5 mg |
| Semaglutide 0.5 mg placebo | Placebo comparator | Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide placebo. Receives: Drug: Placebo (semaglutide 0.5 mg) |
| Semaglutide 1.0 mg | Experimental | Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide. Receives: Drug: Semaglutide 1.0 mg |
| Semaglutide 1.0 mg placebo | Placebo comparator | Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide placebo. Receives: Drug: Placebo (semaglutide 1.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after last administration of semaglutide
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after last administration of semaglutide
Secondary outcomes (13)
Maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after last administration of semaglutide
Time to maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after last administration of semaglutide
Total apparent clearance of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after last administration of semaglutide
Terminal elimination half-life of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Measured: 0-840 hours after last administration of semaglutide
Apparent volume of distribution of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Measured: 0-840 hours after last administration of semaglutide
Trough plasma semaglutide concentration
Calculated based on semaglutide measured in blood.
Measured: Before dosing at day 29, 57, 78, 85 and 92
Dose-corrected accumulation ratio
Calculated based on semaglutide measured in blood.
Measured: Based on the area under the semaglutide plasma concentration curve from 0-168 hours after the first dose and the area under the semaglutide plasma concentration curve 0-168 hours after the last dose
Area under the semaglutide plasma concentration time curve
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Time to maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Measured: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Number of treatment emergent adverse events (TEAEs)
Count and % of adverse events
Measured: Visit 2 (Day 1) - visit 23 (Day 120-127)
Number of hypoglycaemic episodes
Count of episodes
Measured: Visit 2 (Day 1) - visit 23 (Day 120-127)
Incidence of anti-semaglutide antibodies (positive/negative) at follow-up
Count of episodes
Measured: Visit 23 (Day 120-127)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start21 Sep 2017
- Primary completion10 Jul 2018
- Study completion7 Aug 2018
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 DiabetesStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288740
- Sponsor's protocol ID
- NN9535-3686
- Other IDs
- U1111-1149-6572
- Status last verified
- Feb 2021
- First submitted
- 18 Sep 2017
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Shi A, Xie P, Nielsen LL, Skjoth TV, He X, Haugaard SP. Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial. Adv Ther. 2021 Jan;38(1):550-561. doi: 10.1007/s12325-020-01548-y. Epub 2020 Nov 7.
PubMed 33159658
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT03288740
- Acronym / sponsor ID
- NN9535-3686
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 20 Sep 2017 (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.
The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. The total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 0.5 mg | Experimental | Drug: Semaglutide 0.5 mgParticipants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide. |
| Semaglutide 0.5 mg placebo | Placebo comparator | Drug: Placebo (semaglutide 0.5 mg)Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide placebo. |
| Semaglutide 1.0 mg | Experimental | Drug: Semaglutide 1.0 mgParticipants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide. |
| Semaglutide 1.0 mg placebo | Placebo comparator | Drug: Placebo (semaglutide 1.0 mg)Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female Chinese subjects
- Age between 18 to 55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 20 and 24.9 kg/sqm (both inclusive)
- Body weight greater than or equal to 54.0 kg
Key exclusion criteria (7 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method throughout the trial including follow-up period. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or barrier methods
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic products (including routine or non-routine vitamins or herbal products) or topical medicinal products (except paracetamol and oral contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (randomisation)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of pancreatitis (acute or chronic)
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 |
|---|---|---|
| Semaglutide 0.5 mgA dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks. | Drug | Semaglutide 0.5 mg |
| Placebo (semaglutide 0.5 mg)A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks. | Drug | Semaglutide 0.5 mg placebo |
| Semaglutide 1.0 mgA dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks. | Drug | Semaglutide 1.0 mg |
| Placebo (semaglutide 1.0 mg)A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks. | Drug | Semaglutide 1.0 mg placebo |
Primary outcome
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)
Time frame: 0-168 hours after last administration of semaglutide
Calculated based on semaglutide measured in blood.
13 secondary outcomes
Maximum observed semaglutide plasma concentration at steady state
Time frame: 0-168 hours after last administration of semaglutide
Time to maximum observed semaglutide plasma concentration at steady state
Time frame: 0-168 hours after last administration of semaglutide
Total apparent clearance of semaglutide at steady state
Time frame: 0-168 hours after last administration of semaglutide
Terminal elimination half-life of semaglutide at steady state
Time frame: 0-840 hours after last administration of semaglutide
Apparent volume of distribution of semaglutide at steady state
Time frame: 0-840 hours after last administration of semaglutide
Trough plasma semaglutide concentration
Time frame: Before dosing at day 29, 57, 78, 85 and 92
Dose-corrected accumulation ratio
Time frame: Based on the area under the semaglutide plasma concentration curve from 0-168 hours after the first dose and the area under the semaglutide plasma concentration curve 0-168 hours after the last dose
Area under the semaglutide plasma concentration time curve
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Maximum observed semaglutide plasma concentration
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Time to maximum observed semaglutide plasma concentration
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Number of treatment emergent adverse events (TEAEs)
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Number of hypoglycaemic episodes
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Incidence of anti-semaglutide antibodies (positive/negative) at follow-up
Time frame: Visit 23 (Day 120-127)
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 15 Feb 2021.
- Results publication: PubMed 33159658Shi A, Xie P, Nielsen LL, Skjoth TV, He X, Haugaard SP. Pharmacokinetics, Safety and Tolerability of Once-Weekly Subcutaneous Semaglutide in Healthy Chinese Subjects: A Double-Blind, Phase 1, Randomized Controlled Trial. Adv Ther. 2021 Jan;38(1):550-561. doi: 10.1007/s12325-020-01548-y. Epub 2020 Nov 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Semaglutide 0.5 mg and Semaglutide 1.0 mg in people with Diabetes 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 7 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 15 Feb 2021. 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?
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg) (time frame: 0-168 hours after last administration of semaglutide). The study lists 2 primary outcomes in all. 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 NCT03288740, 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 15 Feb 2021.