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Clinical Trials List

Protocol Number1404-0040

NCT Number(ClinicalTrials.gov Identfier)NCT06077864

Active

2024-01-01 - 2026-12-31

Phase III

Not yet recruiting5

Recruiting1

A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD

Trial Applicant

Boehringer Ingelheim
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 李立昂無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 周莒光無

Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 杜思德無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Kuo-Chin Huang 無

National Taiwan University Hospital

Co-Principal Investigator

盧佳文無
張皓翔無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Yuan Lin 無

China Medical University Hospital

Co-Principal Investigator

Hua-Shui Hsu 無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Obesity

Objectives

The primary objective was to evaluate the outcome based on any major composite outcome measure (defined as CV death, nonfatal stroke, nonfatal myocardial infarction (MI), ischemia-related coronary revascularization, or heart failure events (HFE) ), that is, the Cox regression of the time to first occurrence of the determinant factor of 5-point major adverse cardiac event (5P-MACE), demonstrated through the risk ratio (BI 456906 compared to placebo) that BI 456906 Noninferiority of 3.6 mg and 6.0 mg (pooled) compared to placebo. The primary treatment comparison will be similarly randomized and include the impact of any early discontinuation of treatment or any withholding of treatment. Secondary purposes are: ‧ The first occurrence of a criterion based on any composite measure (defined as CV death, nonfatal stroke, or nonfatal MI (i.e., 3-point major adverse cardiac event (3P-MACE))) Cox regression over time demonstrated non-inferiority of BI 456906 3.6 mg and 6.0 mg (pooled) compared to placebo as measured by risk ratio (BI 456906 compared to placebo). ‧ Demonstrated superiority of BI 456906 6.0 mg in absolute change-adjusted mean differences in systolic blood pressure (SBP) (mmHg) from baseline to week 72 ‧ Demonstrated superiority of BI 456906 3.6 mg in absolute change-adjusted mean differences in SBP (mmHg) from baseline to week 72 ‧ Demonstrated superiority of adjusted mean differences in absolute changes in waist circumference (reflecting visceral fat, centimeters [cm]) from baseline to week 72 for BI 456906 6.0 mg ‧ Demonstrated superiority of BI 456906 3.6 mg in adjusted mean differences in absolute changes in waist circumference (reflecting visceral fat, cm) from baseline to week 72 ‧ Demonstrated that BI 456906 3.6 and 6.0 mg (pooled) improved Kansas City Cardiomyopathy Questionnaire global symptom scores from baseline to Week 72 in trial participants with heart failure (HF) at baseline. Advantages of Adjusted Mean Differences in Absolute Changes in Total Symptom Score, KCCQ-TTS) ‧ Demonstration of risk ratios based on Cox regression of time to first occurrence of any of the major composite assessments defined as CV death, nonfatal stroke, nonfatal MI, ischemia-related coronary revascularization, or HFE (5P-MACE) Advantages of BI 456906 3.6 and 6.0 mg (pooled) versus placebo

Test Drug

BI 456906

Active Ingredient

BI 456906

Dosage Form

Solution for injection

Dosage

0.6 mg/mL, 1.2 mg/mL, 2.4 mg/mL, 4.8 mg/mL, 7.2 mg/mL, 9.6 mg/mL, 12 mg/mL

Endpoints

Main evaluation indicators
‧ Time to first occurrence of any component of the composite assessment, including: CV death, nonfatal stroke, nonfatal MI, ischemia-related coronary revascularization, or HFE (this includes hospitalization for heart failure, HHF], emergency room visit, urgent care visit, or urgent outpatient HF visit) (5P-MACE) (to demonstrate non-inferiority)

Inclution Criteria

Inclusion Criteria:

-Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years.
-Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

Exclusion Criteria

Exclusion criteria:

-Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
-Type 1 diabetes.
-Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.
-Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

The Estimated Number of Participants

Taiwan

56 participants
Global

4935 participants