Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

What Was Tested

The trial (phase 3) is built around Mazdutide.

It had two arms (groups): IBI362 treatment Group (experimental) and Placebo Control Group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 336 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Aged ≥ 18 years old at the time of signing the informed consent form. Confirmed diagnosis of hypertension.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: the investigator suspects that the participant may be allergic to the components of the study drug or drugs of the same class; history of orthostatic hypotension, or blood pressure measured at screening meeting the criteria for orthostatic hypotension; concurrent use of beta-blockers within 1 month prior to screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-04-23 with completion listed for 2026-08-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment (time frame: Week 16).

It also tracked 30 secondary outcomes, for example To evaluate the effect of IBI362 on Mean Sitting Systolic Arterial Pressure(msSBP) compared with placebo at Week 24 of treatment, To evaluate the effect of IBI362 on body weight compared with placebo at Weeks 16 and 24 of treatment, During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo, During treatment, IBI362 was evaluated for the effects of IBI362 on body weight compared with placebo, During treatment, IBI362 was evaluated for the effects of IBI362 on body mass index (BMI) compared with placebo and During treatment, IBI362 was evaluated for the effects of IBI362 on waist circumference compared with placebo.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 336 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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