Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.

What Was Tested

The trial (phase 1) is built around Semaglutide.

Follow-up for 5 weeks after administrtion.

It had two arms (groups): Experimental group (experimental) and Active Comparator (active comparator).

The registry classes the interventions as drug.

Who Took Part

68 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Voluntarily participate in the trial and sign the informed consent; Willing and able, in the investigator\'s judgment, to comply with all experimental requirements and restrictions;. Healthy men and women, aged 18 to 55 years old (including);. Body mass index (BMI) 19.0\~25.0 kg/m2 (including), weight ≥50.0 kg;.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history;; subjects with a history of acute and chronic pancreatitis, symptomatic gallbladder history, pancreatic injury history and other high-risk factors that may lead to pancreatitis;; in the screening period, calcitonin was greater than the upper limit of normal;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-09-22 with completion listed for 2024-11-14.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUC0-inf. AUC0-t. Cmax.

It also tracked 6 secondary outcomes, for example AUC_%Extrap, Tmax, t 1/2, λz, CL and Safety and Immunogenicity.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 68 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.