A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

What Was Tested

The trial (phase 3) is built around Mazdutide.

A total of 912 subjects will be enrolled.

It had three arms (groups): Experimental group: HDM1005 1 (experimental), Experimental group: HDM1005 2 (experimental) and Active Comparator: Mazdutide (active comparator).

HDM1005 administered subcutaneously (SC).

HDM1005 administered SC.

Mazdutide administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 912 planned participants were the target.

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: Body Mass Index (BMI) ≥22.5 kg/m2.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: other types of diabetes besides t2dm; history of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the icf; history or family history of medullary thyroid carcinoma (mtc), thyroid c-cell hyperplasia, or multiple endocrine neoplasia type 2 (men2).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Mazdutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2026-03-27 with completion listed for 2027-08-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40).

It also tracked 4 secondary outcomes, for example Change from baseline in HbA1c, Change from baseline in fasting plasma glucose (FPG) and Change from baseline in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 912 people.

With 912 participants it is a large trial for this field.

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

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