GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

A Single-centre, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-24.9•Healthy volunteers

Primary endpoints

•AUC of semaglutide at steady state (semaglutide 0.5 mg)•AUC of semaglutide at steady state (semaglutide 1.0 mg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03288740

Org study IDNN9535-3686

Secondary IDU1111-1149-6572World Health Organization (WHO)

Timeline

Milestones

Study first posted2017-09-20actual

Study start2017-09-21actual

Primary completion2018-07-10actual

Study completion2018-08-07actual

Last update posted2021-02-15actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.