Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

What Was Tested

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

The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

It had three arms (groups): IBI362 - Mild and Moderate Renal Impairment (experimental), IBI362 - Healthy (experimental) and IBI362 - Severe Renal Impairment (experimental).

Group 2 - IBI362 administered SC to participants with mild and moderate renal impairment.

Group 1 - IBI362 administered subcutaneously (SC) to healthy participants with normal renal function.

Group 3 - IBI362 administered SC to participants with severe renal impairment.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Participants with Renal Impairment:. Males or females with stable mild to severe renal impairment, assessed by eGFR.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: all participants:; have known allergies to ibi362 or related compounds; have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

Being open-label, the Mazdutide study did not mask who received what.

It started in 2023-05-05 with completion listed for 2023-09-18.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362 (time frame: Predose through 1344 hours postdose).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Mazdutide in 20 people.

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

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

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