A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288740
• Other study ID #: NN9535-3686
• Secondary ID: U1111-1149-6572
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2017
• Est. completion date: August 7, 2018

Study information

• Verified date: February 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 7, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide 0.5 mg
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)
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 mg
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)
A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

References & Publications (1)

Shi A, Xie P, Nielsen LL, Skjøth 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)	Calculated based on semaglutide measured in blood.	0-168 hours after last administration of semaglutide
Primary	Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)	Calculated based on semaglutide measured in blood.	0-168 hours after last administration of semaglutide
Secondary	Maximum observed semaglutide plasma concentration at steady state	Calculated based on semaglutide measured in blood.	0-168 hours after last administration of semaglutide
Secondary	Time to maximum observed semaglutide plasma concentration at steady state	Calculated based on semaglutide measured in blood.	0-168 hours after last administration of semaglutide
Secondary	Total apparent clearance of semaglutide at steady state	Calculated based on semaglutide measured in blood.	0-168 hours after last administration of semaglutide
Secondary	Terminal elimination half-life of semaglutide at steady state	Calculated based on semaglutide measured in blood.	0-840 hours after last administration of semaglutide
Secondary	Apparent volume of distribution of semaglutide at steady state	Calculated based on semaglutide measured in blood.	0-840 hours after last administration of semaglutide
Secondary	Trough plasma semaglutide concentration	Calculated based on semaglutide measured in blood.	Before dosing at day 29, 57, 78, 85 and 92
Secondary	Dose-corrected accumulation ratio	Calculated based on semaglutide measured in blood.	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
Secondary	Area under the semaglutide plasma concentration time curve	Calculated based on semaglutide measured in blood.	0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Secondary	Maximum observed semaglutide plasma concentration	Calculated based on semaglutide measured in blood.	0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Secondary	Time to maximum observed semaglutide plasma concentration	Calculated based on semaglutide measured in blood.	0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Secondary	Number of treatment emergent adverse events (TEAEs)	Count and % of adverse events	Visit 2 (Day 1) - visit 23 (Day 120-127)
Secondary	Number of hypoglycaemic episodes	Count of episodes	Visit 2 (Day 1) - visit 23 (Day 120-127)
Secondary	Incidence of anti-semaglutide antibodies (positive/negative) at follow-up	Count of episodes	Visit 23 (Day 120-127)