A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

Официальное название

A Multicenter, Randomized, Open-label, Parallel-controlled, Phase 3 Study to Compare the Efficacy and Safety of HDM1005 Versus Mazdutide in Subjects With T2DM Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

Обзор

This study is a multicenter, randomized, open-label, parallel-group, phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus active comparator in subjects with Type 2 Diabetes Mellitus (T2DM) Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. A total of 912 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and metformin monotherapy (yes or no), then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (active comparator), with 304 subjects in each treatment group. All treatment groups will implement dose titration to achieve the target dose. The study consists of: up to 2-week screening, 2-week run-in, 40-week core treatment, 12-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.

Вмешательства

• Препарат HDM1005 1
  administered SC, QW, 52 week
• Препарат HDM1005 2
  administered SC, QW, 52 week
• Препарат Mazdutide
  administered SC, QW, 52 week

Первичные конечные точки

• Change from baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, Week 40]

Вторичные конечные точки (4)

• Change from baseline in HbA1c [Срок оценки: Baseline, Week 52]
• The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7% [Срок оценки: Week 40, Week 52]
• Change from baseline in fasting plasma glucose (FPG) [Срок оценки: Baseline, Week 40, Week 52]
• Change from baseline in body weight [Срок оценки: Baseline, Week 40, Week 52]

Критерии участия

Критерии включения

• Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and on a stable dosage of metformin alone or in combination with an SGLT2 inhibitor for at least 12 weeks prior to screening.
• Hemoglobin A1c (HbA1c) ≥7.5% and ≤11.0% (local laboratory) at screening; and ≥7.0% and ≤11.0% (central laboratory) at randomization.
• Body Mass Index (BMI) ≥22.5 kg/m2.

Критерии исключения

• Other types of diabetes besides T2DM.
• Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).
• History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF.
• History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
• History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease requiring treatment per investigator's assessment within 24 weeks prior to signing the ICF.
• Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis.
• Use of antidiabetic medications within 12 weeks prior to signing the ICF, with the exception of metformin monotherapy or combination therapy with an SGLT2 inhibitor; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.
• Hemoglobin (Hb) <100 g/L (female) or <110 g/L (male).
• FPG ≥13.9 mmol/L.
• Aspartate aminotransferase (AST) >3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3× ULN.
• Total bilirubin >1.5× ULN.
• Fasting triglyceride (TG) >5.6 mmol/L (500 mg/dL).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07417306 · HDM1005-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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