Back to resultsA Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Semaglutide 0.5 mg
Placebo (semaglutide 0.5 mg)
Semaglutide 1.0 mg
Placebo (semaglutide 1.0 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Semaglutide 0.5 mg
Semaglutide 0.5 mg placebo
Semaglutide 1.0 mg
Semaglutide 1.0 mg placebo
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)
Calculated based on semaglutide measured in blood.
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)
Calculated based on semaglutide measured in blood.
Secondary Outcome Measures
Maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Time to maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Total apparent clearance of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Terminal elimination half-life of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Apparent volume of distribution of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Trough plasma semaglutide concentration
Calculated based on semaglutide measured in blood.
Dose-corrected accumulation ratio
Calculated based on semaglutide measured in blood.
Area under the semaglutide plasma concentration time curve
Calculated based on semaglutide measured in blood.
Maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Time to maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Number of treatment emergent adverse events (TEAEs)
Count and % of adverse events
Number of hypoglycaemic episodes
Count of episodes
Incidence of anti-semaglutide antibodies (positive/negative) at follow-up
Count of episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03288740
Brief Title
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
August 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide 0.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Semaglutide 0.5 mg placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Semaglutide 1.0 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Semaglutide 1.0 mg placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 0.5 mg
Intervention Description
A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo (semaglutide 0.5 mg)
Intervention Description
A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 1.0 mg
Intervention Description
A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo (semaglutide 1.0 mg)
Intervention Description
A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Primary Outcome Measure Information:
Title
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after last administration of semaglutide
Title
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after last administration of semaglutide
Secondary Outcome Measure Information:
Title
Maximum observed semaglutide plasma concentration at steady state
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after last administration of semaglutide
Title
Time to maximum observed semaglutide plasma concentration at steady state
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after last administration of semaglutide
Title
Total apparent clearance of semaglutide at steady state
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after last administration of semaglutide
Title
Terminal elimination half-life of semaglutide at steady state
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-840 hours after last administration of semaglutide
Title
Apparent volume of distribution of semaglutide at steady state
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-840 hours after last administration of semaglutide
Title
Trough plasma semaglutide concentration
Description
Calculated based on semaglutide measured in blood.
Time Frame
Before dosing at day 29, 57, 78, 85 and 92
Title
Dose-corrected accumulation ratio
Description
Calculated based on semaglutide measured in blood.
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
Title
Area under the semaglutide plasma concentration time curve
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Title
Maximum observed semaglutide plasma concentration
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Title
Time to maximum observed semaglutide plasma concentration
Description
Calculated based on semaglutide measured in blood.
Time Frame
0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Title
Number of treatment emergent adverse events (TEAEs)
Description
Count and % of adverse events
Time Frame
Visit 2 (Day 1) - visit 23 (Day 120-127)
Title
Number of hypoglycaemic episodes
Description
Count of episodes
Time Frame
Visit 2 (Day 1) - visit 23 (Day 120-127)
Title
Incidence of anti-semaglutide antibodies (positive/negative) at follow-up
Description
Count of episodes
Time Frame
Visit 23 (Day 120-127)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Citations:
PubMed Identifier
33159658
Citation
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.
Results Reference
result
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A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
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