A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity

What Was Tested

This registered phase 3 trial tested Semaglutide.

It had two arms (groups): Treatment group A: HRS9531 injection (experimental) and Treatment group B: Semaglutide Injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 572 actual participants took part.

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: With my consent and has signed the informed consent form, I am willing and able to follow the requirements of the trial protocol to complete this study;. Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;. Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.

The full record lists 5 inclusion and 26 exclusion criteria; among the exclusions: those with abnormal relevant examinations at screening;; ECG results are abnormal and may affect the safety of the subject; poor blood pressure control.

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.

The Semaglutide group and the comparison group ran side by side rather than switching.

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

It started in 2025-12-25 with completion listed for 2027-03.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage change from baseline in body weight after 52 weeks of treatment (time frame: 52 weeks).

It also tracked 10 secondary outcomes, for example Change from baseline in waist circumference,after 52 weeks of treatment, Change from baseline in body weight after 52 weeks of treatment, Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment, Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment, Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment and Change from baseline in liver enzymes after 52 weeks of treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 572 people.

With 572 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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