A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

14 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: He/She should provide written informed consent. He/She must be a healthy adult human male or non-pregnant, non-lactating females,18 - 45 years of age (both years inclusive). He/She should have a body mass index ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 with body weight at least 55 kg for men and at least 48 kg for women. He/She should have pulse rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14 breaths/min and not more than 18 breaths/min. He/She should have normal ECG, chest X-ray and vital signs.

The full record lists 10 inclusion and 24 exclusion criteria; among the exclusions: he/she is incapable of understanding the informed consent; he/she has a history of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function; he/she has a history of tuberculosis, epilepsy, asthma, diabetes, psychosis and eye disorders.

How the Study Was Run

It was run as a non-randomized, sequential and open-label study.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2024-08 with completion listed for 2024-11.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cmax (time frame: From time zero up to the last time point with measurable concentration). AUC0-t (time frame: From time zero up to the last time point with measurable concentration). AUC0-inf (time frame: From time zero up to the last time point with measurable concentration).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Semaglutide in 14 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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