Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes

What Was Tested

The trial (phase 2) is built around Tirzepatide.

All participants received a lifestyle intervention that involved counselling on diet and physical activity.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and tirzepatide injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 372 planned participants were the target.

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: The age of signing ICF was from 18 to 65 years old (including both ends), regardless of gender. BMI ≥28.0 but \<40.0 kg/m2 at screening and randomization.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: previous diagnosis of type 1, type 2, or any other type of diabetes; history or family history of medullary thyroid carcinoma, c cell hyperplasia, or multiple endocrine neoplasia type; previous or combined presence or suspicion of depression or other psychiatric disorders or screening phq-9 score ≥15.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-03-31 with completion listed for 2027-02-04.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary Outcome (time frame: week 40).

It also tracked 16 secondary outcomes, for example Secondary Outcome, Secondary Outcome, Secondary Outcome, Secondary Outcome, Secondary Outcome and Secondary Outcome.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 372 people.

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

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