Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

What Was Tested

The trial (phase 1, phase 2) is built around Mazdutide.

This trial is conducted in China.

It had two arms (groups): IBI362 (experimental) and placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have stable body weight for the past 12 weeks prior to screening. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: have a diagnosis of type 2 diabetes; have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening; previous treatment with a glp-1 (glucagon-like peptide 1) receptor agonists or gcg(glucagon)receptor agonists before.

How the Study Was Run

The set-up was randomized, sequential and double-blind.

The participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

Blinding on both sides kept the participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant and investigator.

It started in 2020-06-16 with completion listed for 2021-06-16.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of treatment adverse events.

It also tracked 8 secondary outcomes, for example Number of Participants With Anti-IBI362 Antibodies, Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;, Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;, Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;, Evaluate the Glucagon of IBI362 in overweight or obesity subjects; and Evaluate the Insulin of IBI362 in overweight or obesity subjects;.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Mazdutide in 60 people.

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.