A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin

What Was Tested

The trial (phase 2) is built around Tirzepatide.

The study consists of four periods: a 2-week screening period, a 3-week run-in period, a 28-week treatment period and a 3-week safety follow-up period.

A total of 240 subjects will be enrolled.

It had six arms (groups): SYH2069 Injection (group 1) (experimental), SYH2069 Injection (group2) (experimental), SYH2069 Injection (group 3) (experimental), SYH2069 Injection (group 4) (experimental) and SYH2069 Injection placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 240 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: 1\. Male or female participants, 18-75 years of age. 2\. Confirmed as T2DM for at least 12 weeks. 3\. Body Mass Index (BMI): 22 kg/m\^2 ≤ BMI ≤ 40 kg/m\^2. 4\. Treated with lifestyle intervention and stable treatment with metformin at least 8 weeks prior to screening. 6\. Able to understand the protocol, and voluntarily signed informed consent.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: 1\. type 1 diabetes or other specific types of diabetes; 2\. allergy to any active ingredient or any excipient of the investigational product, or presence of severe allergic diseases at screening; 4\. history of a level 3 hypoglycemic episode within 6 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2026-11-06 with completion listed for 2027-09-28.

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 28).

It also tracked 11 secondary outcomes, for example Change from Baseline in Fasting Plasma Glucose (FPG), Change from baseline in 2-hour postprandial plasma glucose (2h-PPG), Change from body weight, Change from waist circumference, Change from hip circumference and Change from waist-to-hip ratio.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 240 people.

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

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