Study of IPG1094 Tablets in Chinese Healthy Adults and Obese Adults

Who can take part

• Male and female Chinese participants aged 18-50 years inclusive
• Part A/B (healthy adults): Physical examination, vital signs, 12-lead ECG, chest X-ray, laboratory tests are normal or abnormalities considered not clinically significant by investigator; male body weight ≥50.0 kg, female ≥45.0 kg; BMI 19.0-26.0 kg/m²
• Part C (obese adults): BMI 28.0-35.0 kg/m²; body weight stable within 3 months prior to screening (weight change ≤5%). No concomitant diseases interfering with safety, PK or weight evaluation
• Female participants are non-pregnant and non-lactating
• All participants (male and female) agree to use effective contraception from informed consent through 6 months after last study drug administration; no plan for pregnancy, sperm / oocyte donation
• For Part C: Able to complete hospitalization for first 10 days, outpatient visits, home drug administration and study diary; refrain from additional weight-loss medications, bariatric surgery or intensive weight-loss programs
• Voluntarily sign written informed consent form

Who cannot take part

• Blood donation ≥400 mL within 3 months before screening
• Major surgery within 3 months before screening or planned surgery during study
• Alcohol or substance abuse history; positive drug-of-abuse screen or positive alcohol breath test
• Use of metformin or other biguanides within 3 months before screening; systemic glucocorticoids within 1 month before screening; CYP-modifying drugs within 30 days before screening; prescription/OTC/herbal products within 14 days before screening
• Vaccines or biological agents within 4 months pre-screening or planned during study
• Participation in another interventional clinical trial within 3 months before screening
• Acute disease within 14 days prior to screening
• History of severe/uncontrolled cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immune, dermatological, neurological or psychiatric diseases with ongoing clinical significance
• History of orthostatic hypotension, dysphagia
• Gastrointestinal disorders affecting drug absorption
• Known hypersensitivity to study drug or placebo excipients
• Difficult venous access, history of needle-phobia
• Other conditions judged inappropriate for enrollment by investigator. Additional Exclusion for Part C (obese participants)： Fasting glucose ≥11.0 mmol/L or HbA1c ≥8.0%; secondary obesity, eating disorders, clinically significant cardiovascular disease, moderate-severe obstructive sleep apnea, active liver disease, significant renal impairment; Repeated BP: SBP ≥160 mmHg or DBP ≥100 mmHg; ALT/AST >2×ULN; total bilirubin >1.5×ULN; eGFR <60 mL/min/1.73 m²; Weight-loss drugs, intensive weight-loss program within 3-month pre-screening; prior or planned bariatric surgery
• ECG: QTcF >450 ms (male) / >470 ms (female)
• Recurrent headache/migraine, recurrent nausea/vomiting
• Cannot comply with unified diet requirements, lactose intolerance
• Excessive alcohol / tobacco / caffeine intake defined per protocol
• Consumption of grapefruit / citrus fruits/juice within 5 days pre-screening and refusal to abstain during study