BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Semaglutide.

The main questions it aims to answer are: Does Bofanglutide (GZR18) provide glycemic control comparable to Semaglutide based on changes in HbA1c?

It had two arms (groups): Arm 1: Bofanglutide (GZR18) (experimental) and Arm 2: Semaglutide (active comparator).

The registry classes the interventions as biological.

Who Took Part

Enrollment: 374 planned participants were the target.

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: Adults aged 18 years and older who agree to participate in the study by voluntarily signing the Informed Consent Form. Adult participants of either male or female sex. Body mass index (BMI) ≥27 kg/m².

The full record lists 9 inclusion and 39 exclusion criteria; among the exclusions: known or suspected hypersensitivity to glp-1 type drugs or any of their excipients; or presence of contraindications for this type of medication; participation in clinical trials of other drugs or devices and having received treatment within the 3 months prior to the screening period; current use of non-antidiabetic medications that affect body weight.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

It started in 2026-09 with completion listed for 2027-10.

It ran at 7 sites in Mexico (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30 (time frame: Baseline to Week 30).

It also tracked 6 secondary outcomes, for example Change in Fasting Plasma Glucose From Baseline at Week 30, Change in Hemoglobin A1c (HbA1c) From Baseline at Week 16, Change in Body Weight From Baseline at Week 30, Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Total Score From Baseline at Week 33 and Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Total Score From Baseline at Week 30.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 374 people.

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

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