Phase 2 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity

Korábbi kezelés

• Known hypersensitivity to GLP-1 receptor agonists, any component of the investigational product, or history of severe allergic disease or severe drug allergy.

Laborértékek

• Use of medications that may affect glucose metabolism or body weight before screening, including antidiabetic drugs, systemic glucocorticoids, psychotropic drugs associated with weight change, prescription weight-loss drugs within 12 weeks, or over-the-counter weight-loss drugs/appetite suppressants within 4 weeks.
• Clinically significant laboratory abnormalities at screening or before randomization, including:
  • ALT or AST ≥3 × ULN, or TBIL ≥1.5 × ULN.
  • eGFR <60 mL/min/1.73 m².
  • Hemoglobin <110 g/L in males or <100 g/L in females.
  • Calcitonin ≥35 ng/L.
  • TSH >6.0 or <0.4 mIU/L.
  • Fasting triglycerides ≥5.64 mmol/L.
  • Amylase or lipase >2 × ULN.
• History or presence of clinically significant diseases or conditions that may affect body weight, safety, or study assessments, including:
  • Secondary or drug-induced overweight/obesity.
  • Type 1 or type 2 diabetes mellitus, or laboratory evidence of diabetes (HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or random/2-hour OGTT plasma glucose ≥11.1 mmol/L).
  • Acute or chronic pancreatitis or pancreatic injury.
  • Gallstones or cholecystitis, except adequately treated cases without residual disease.
  • Medullary thyroid carcinoma, MEN 2A/2B, or relevant family history.
  • Previous bariatric surgery or planned procedures that may significantly affect body weight.
  • Moderate or severe depression, PHQ-9 score ≥15, severe psychiatric disorders, suicidal ideation/behavior, or suicide risk.
  • Malignancy within 5 years, except specified adequately treated localized cancers.
  • Significant cardiovascular or cerebrovascular disease within 6 months before screening/randomization.
  • Osteoporosis defined as T-score ≤-2.5 or Z-score ≤-2.0, as applicable.
  • Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg).
  • Clinically significant thyroid dysfunction.
  • Significant gastric emptying disorders or active gastrointestinal disease.
  • History of organ transplantation or awaiting transplantation.
  • Autoimmune diseases likely to require systemic glucocorticoids.
  • Current participation in an active weight-loss program not yet in the maintenance phase.

• Male or female participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF).
• Body weight ≥ 70 kg (male) or ≥ 60 kg (female), with body mass index (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI < 30 kg/m² (overweight) accompanied by at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, or polycystic ovary syndrome).
• Self-reported or documented diet and exercise control of body weight for 12 weeks or more, with body weight change of less than 5.0% within 12 weeks prior to screening.