A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypert… (NCT06555640) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia
China79 participantsStarted 2024-08-01
Plain-language summary
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the efficacy of DR10624 on fasting serum triglyceride (TG) levels after 12 weeks of treatment in subjects with severe hypertriglyceridemia (SHTG).
Who can participate
Age range17 Years – 75 Years
SexALL
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Inclusion criteria
✓.Male or female, age of 18 to 75 years (inclusive) at screening.
✓.Subjects must have a BMI of \>19 kg/m2 and BMI of ≤45.0 kg/m2 , and body weight ≥50 Kg at screening.
✓.During screening or within 1 week prior to screening, the TG levels should meet the following criteria: 4.80 mmol/L (425 mg/dL) ≤ fasting TG \< 22.60 mmol/L (2000 mg/dL).
✓.The average fasting TG level of Visit 2 and Visit 3 values must meet: 5.65 mmol/L (500 mg/dL) ≤fasting TG \<22.60 mmol/L(2000 mg/dL); or the average fasting TG level of Visit 3 and Visit 3.1 values must meet the same criteria.
✓.Subjects will able to accept rencommendation on therapeutic lifestyle modificationa and maintain a stable lifestyle for the duration of the study.
✓.Subjects who are receiving statins, cholesterol-absorption inhibitor (CAI), fibrates, niacin ≥500 mg/day, or prescription omega-3 fish oil must have achieved a stable dose for at least 4 weeks before screening.
✓.Subjects diagnosed with type 2 diabetes(T2DM) must have a glycosylated hemoglobin level at screening of\<9.5%(80 mmol/mol）and treated with lifestyle modification or a stable doses of antidiabetic medications for at least 8 weeks prior to screening.
Exclusion criteria
✕.Subjects who have lost ≥5% of body weight within 3 months prior to screening, or who lose ≥5% of body weight during screening, or who plan to lose body weight during the study.
✕.Subjects with type 1 diabetes, or nephrotic syndrome.
.Subjects with cirrhosis, alcoholic liver disease, liver failure, liver cancer, or autoimmune hepatitis.
✕.Subjects type 2 diabetes with a duration of less than 12 weeks or with severe complications.
✕.Uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg under medication conditions.
✕.Subjects with an active or untreated malignancy or who have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \<5 years prior to screening.
✕.Subjects with a family or personal history of medullary thyroid carcinoma (MTC),multiple endocrine neoplasia syndrome type 2 (MEN2),severe active or unstable major depressive disorder (MDD), or other serious mental disorders (such as schizophrenia, bipolar disorder, or other severe mood or anxiety disorders) or suicidal.
✕.Subjects with a known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis), and who have undergone or plan to undergo gastric bypass surgery or gastric banding surgery during the study, or those who chronically take drugs that directly affect GI motility.