Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

What Was Tested

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

The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

It had four arms (groups): Group A (experimental), Group B (experimental), Group C (experimental) and Group D (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 64 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes; have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;; participants in clinical trials of any drug or medical device in the 3 months prior to screening.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2022-10-12 with completion listed for 2023-05-24.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of Adverse Events (Safety and Tolerability) (time frame: Screening period up to Day 62).

It also tracked 6 secondary outcomes, for example Area Under the Concentration Versus Time Curve (AUC) of HRS9531, Maximum Concentration (Cmax) of HRS9531, Change from Baseline in Fasting Blood Glucose (FBG), Change from Baseline in Hemoglobin A1c (HbA1c), Change from Baseline in Weight and Immunogenicity: anti-HRS9531 antibody.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 64 people.

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

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