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New diabetes drug BGM0504 takes on semaglutide in major trial

NCT ID NCT07064486

Disease control Sponsor: BrightGene Bio-Medical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares a new injectable drug, BGM0504, to the established drug semaglutide (Ozempic) in 477 adults with type 2 diabetes. All participants also take metformin. The study measures how well each drug controls blood sugar and weight over 24 weeks. The goal is to see if BGM0504 is a safe and effective alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGM0504 (a new injectable drug for diabetes)
What this could lead to
If successful, BGM0504 could offer a new once-weekly option to help control blood sugar and weight in people with type 2 diabetes.
What could go wrong
This is an early-phase 3 trial, so results may not confirm superiority over semaglutide. Side effects and long-term safety are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 477 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ○ Have been diagnosed with type 2 diabetes mellitus (T2DM); * Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or \<1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening * Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening; * Be of stable weight (± 5%) for at least 3 months before screening; * Have HbA1c between ≥7.5% and ≤11.0% at screening Exclusion Criteria: * ○ Previous diagnosis of type 1 diabetes, special type diabetes; * Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy; * Have the acute or chronic pancreatitis; * Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening; * Have a serious mental illness or speech impediment and be unable to fully understand the study; * Suspected or confirmed history of alcohol or drug abuse; * Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year; * Other conditions that may impact the assessment of investigational products, as determined by the Investigator.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • RS Universitas Indonesia

    RECRUITING

    Depok, West Java, Indonesia

  • RSUP Fatmawati

    RECRUITING

    Jakarta, Indonesia

  • RSUP Persahabatan

    RECRUITING

    Jakarta, Indonesia

  • RSUPN Dr. Cipto Mangunkusumo

    RECRUITING

    Jakarta, Indonesia

More trials for these conditions

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