A Study of BGM0504 in Early T2DM With Obesity
29 juli 2026 uppdaterad av: BrightGene Bio-Medical Technology Co., Ltd.
A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）
This trial is conducted in China.
The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise.
Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
372
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Zhu
- Telefonnummer: +86025-68182432
- E-post: zhudalong@nju.edu.cn
Studieorter
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210008
- Rekrytering
- Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: BGM0504 Injection 15 mg
|
Administered as a subcutaneous injection once weekly for 52 weeks.
|
|
Aktiv komparator: Semaglutide Injection 1.0 mg
|
Administered as a subcutaneous injection once weekly for 52 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline
Tidsram: Week 52
|
Composite endpoint assessing both glycemic control and weight loss.
|
Week 52
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants Achieving Diabetes Remission
Tidsram: Week 64 (12 weeks off treatment)
|
Defined as HbA1c < 6.5% without use of glucose-lowering medications.
|
Week 64 (12 weeks off treatment)
|
|
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline
Tidsram: Weeks 12, 24, 36, 44
|
Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
|
Weeks 12, 24, 36, 44
|
|
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline
Tidsram: Weeks 12, 24, 36, 44, 52
|
Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.
|
Weeks 12, 24, 36, 44, 52
|
|
Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)
Tidsram: Weeks 12, 24, 36, 44, 52
|
Glycemic control assessed at each visit.
|
Weeks 12, 24, 36, 44, 52
|
|
Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline
Tidsram: Weeks 12, 24, 36, 44, 52
|
Composite endpoint assessing stricter glycemic targets combined with weight loss.
|
Weeks 12, 24, 36, 44, 52
|
|
Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment
Tidsram: Week 64
|
Composite of HbA1c < 5.7% or < 6.5% with weight reduction ≥ 5% or ≥ 10%, assessing durability of response after treatment withdrawal.
|
Week 64
|
|
Change from Baseline in HbA1c
Tidsram: Weeks 12, 24, 36, 44, 52
|
Absolute change in glycated hemoglobin from baseline.
|
Weeks 12, 24, 36, 44, 52
|
|
Change from Baseline in Fasting Plasma Glucose (FPG)
Tidsram: Weeks 12, 24, 36, 44, 52
|
Absolute change in fasting glucose from baseline.
|
Weeks 12, 24, 36, 44, 52
|
|
Change from Baseline in 2-Hour Postprandial Glucose
Tidsram: Week 52
|
Glucose measured 2 hours after a standard meal, absolute change from baseline.
|
Week 52
|
|
Change from Baseline in Body Weight
Tidsram: Weeks 12, 24, 36, 44, 52
|
Absolute and percentage change in body weight
|
Weeks 12, 24, 36, 44, 52
|
|
Change from Baseline in BMI
Tidsram: Weeks 12, 24, 36, 44, 52
|
Absolute and percentage change in BMI (kg/m²).
|
Weeks 12, 24, 36, 44, 52
|
|
Change from Baseline in Waist Circumference and Hip Circumference
Tidsram: Weeks 12, 24, 36, 44, 52
|
Absolute change in waist and hip circumference from baseline.
|
Weeks 12, 24, 36, 44, 52
|
|
Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline
Tidsram: Weeks 12, 24, 36, 44, 52
|
Categorical weight loss responders at multiple thresholds.
|
Weeks 12, 24, 36, 44, 52
|
|
Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)
Tidsram: Weeks 12, 24, 36, 44, 52
|
Percentage change in total cholesterol, triglycerides, LDL-C, and HDL-C from baseline.
|
Weeks 12, 24, 36, 44, 52
|
|
Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)
Tidsram: Weeks 12, 24, 36, 44, 52
|
Absolute change in seated SBP and DBP from baseline.
|
Weeks 12, 24, 36, 44, 52
|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Tidsram: Baseline to 64 weeks
|
Includes adverse events, serious adverse events, and hypoglycemic events.
|
Baseline to 64 weeks
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 augusti 2026
Primärt slutförande (Beräknad)
30 september 2028
Avslutad studie (Beräknad)
30 november 2028
Studieregistreringsdatum
Först inskickad
24 juli 2026
Först inskickad som uppfyllde QC-kriterierna
29 juli 2026
Första postat (Faktisk)
4 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BGM0504-Ⅲ -T2DM-03
Läkemedels- och apparatinformation, studiedokument
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Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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