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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: Semaglutide 1.0 mg; Drug: Semaglutide 0.5 mg; Drug: Placebo (semaglutide 1.0 mg); Drug: Placebo (semaglutide 0.5 mg)

• Registration Number: NCT03288740
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2017-09-21
• Primary Completion: 2018-07-10
• Study Completion: 2018-08-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide 1.0 mg	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.
Semaglutide 0.5 mg	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.
Semaglutide 1.0 mg placebo	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.
Semaglutide 0.5 mg placebo	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.

Primary Outcome Measures

Name	Time	Method
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)	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)	0-168 hours after last administration of semaglutide	Calculated based on semaglutide measured in blood.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Beijing, China