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

NCT03288740 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9535-3686U1111-1149-6572
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Maximum observed semaglutide plasma concentration at steady state

  0-168 hours after last administration of semaglutide

• Time to maximum observed semaglutide plasma concentration at steady state

  0-168 hours after last administration of semaglutide

• Total apparent clearance of semaglutide at steady state

  0-168 hours after last administration of semaglutide

• Terminal elimination half-life of semaglutide at steady state

  0-840 hours after last administration of semaglutide

• Apparent volume of distribution of semaglutide at steady state

  0-840 hours after last administration of semaglutide

Study Arms (4)

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.

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.

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.

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.

Drug: Placebo (semaglutide 1.0 mg)

Interventions

Semaglutide 0.5 mg DRUG

A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Semaglutide 0.5 mg

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 0.5 mg placebo

Semaglutide 1.0 mg DRUG

A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.

Semaglutide 1.0 mg

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.

Semaglutide 1.0 mg placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Beijing, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 33159658 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: September 21, 2017
• Primary Completion: July 10, 2018
• Study Completion: August 7, 2018
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)