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Can a new injection outperform semaglutide for diabetes remission?

NCT ID NCT07743983

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental drug called BGM0504 can help people with early-stage type 2 diabetes and obesity achieve better blood sugar control and weight loss than a standard treatment, semaglutide. Participants will receive either BGM0504 or semaglutide as a once-weekly injection for 52 weeks. The study will measure how many people reach a combined goal of lower blood sugar and significant weight loss, and whether some achieve diabetes remission after stopping treatment.

What this could mean

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

Active substance
BGM0504, an experimental once-weekly injection, compared against semaglutide
What this could lead to
If BGM0504 outperforms semaglutide, it could offer a more effective option for managing blood sugar and weight, potentially leading to diabetes remission in early-stage patients.
What could go wrong
This is a phase 3 trial, but success is not guaranteed. BGM0504 may not prove superior to semaglutide, and side effects could limit its use. Results from this trial may not apply to all patients.

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 372 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

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)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening. * BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening. * Have HbA1c between ≥7.5% and ≤10.5% at screening. * FPG ≤15.0 mmol/L at screening. * If hypertensive: SBP \<180 mmHg and DBP \<110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks. * Willing to comply with protocol, use effective contraception, and provide informed consent. Exclusion Criteria: * ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes. * Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months. * History of acute/chronic pancreatitis. * Medullary thyroid carcinoma, MEN 2A/2B, or family history. * Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence). * Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias. * Hemorrhagic or ischemic stroke within 6 months. * Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI). * Pregnant or lactating woman. * Prior clinical trial participation with investigational drug or device within 3 months. * Other situations that are deemed as inappropriate for participation by investigators.

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Conditions

The condition(s) this trial relates to.

obesity disorder 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

    1 site. 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

  • Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）

    RECRUITING

    Nanjing, Jiangsu, 210008, China

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