Phase Ib Clinical Study of MWN109 Injection in Participants With Overweight or Obesity

Korábbi kezelés

• Used GLP-1 receptor agonists or similar drugs targeting the same site, drugs that affect body weight, or weight-loss drugs within 12 weeks before screening.
• Participants with a history or evidence of any of the following diseases:
  • Obesity secondary to other diseases or drug use.
  • Previously or currently diagnosed with type 1 or type 2 diabetes at the time of screening.
  • Previously or currently diagnosed with acute or chronic pancreatitis, or pancreatic injury at the time of screening;.
  • Previous diagnosis of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia type 2A or 2B, or with a relevant family history.
  • Previously undergone gastric weight-loss surgery, or planning to undergo weight-loss surgery, liposuction, or abdominal fat-reduction surgery during the study, which can significantly affect body weight.
  • A history of past or current depression, other severe mental illnesses, or a history of suicidal tendencies or behaviors.
  • Diagnosed with a malignant tumor within 5 years before screening (except for cured carcinoma in situ), or with a potential malignant tumor as evaluated at the time of screening.
  • A history of any of the following heart diseases within 6 months before screening.
  • Suffered from hemorrhagic or ischemic stroke within 6 months before screening and deemed ineligible to participate in this clinical trial by the investigator.
  • Experienced severe hypoglycemia or recurrent (≥ 2 times within 6 months) symptomatic hypoglycemia within 6 months before screening.
  • Participants with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at the time of screening) after treatment, or those with untreated blood pressure reaching the above-mentioned criteria at the time of screening.
  • Abnormal thyroid function that cannot be controlled with a stable drug dosage at the time of screening, or abnormal thyroid function test results with clinical significance that require initiation of treatment at the time of screening.
  • Abdominal ultrasound at the time of screening indicates symptomatic gallbladder polyps or other gallbladder diseases that require treatment, or gallbladder diseases with symptoms that the investigator deems require treatment.
  • Clinically significant gastric emptying abnormalities, gastric reflux disease, active gastrointestinal diseases, etc., present at the time of screening.

Más betegség

• Individuals with a known allergy to GLP - 1 receptor agonist drugs or the excipient components of MWN109 injection, or those with severe allergic diseases or a severe allergic constitution at the time of screening.

Laborértékek

• Laboratory abnormalities: HbA1c ≥ 6.5%, or fasting blood glucose ≥ 7.0 mmol/L, or 2-hour blood glucose in the OGTT≥ 11.1 mmol/L (participants with fasting blood glucose between 6.1 and 6.9 mmol/L at the time of screening need to undergo the OGTT), ALT or AST ≥ 2.5ULN, or total serum bilirubin ≥ 1.5ULN. Serum amylase or serum lipase ≥ 1.5ULN. eGFR< 60 mL/min/1.73 m². Serum calcitonin level ≥ 35 ng/L (pg/mL). TSH> 6.0 mIU/L or < 0.4 mIU/L. Triglycerides ≥ 5.64 mmol/L (500 mg/dL). HGB< 110 g/L (for males) or < 100 g/L (for females).
• ECG shows second- or third-degree atrioventricular block, long QT syndrome (QTcF > 470 ms for females or > 450 ms for males), pre-excitation syndrome, or other ECG abnormalities that the investigator deems require drug intervention.

• Male or female individuals aged between 18 and 65 years old (inclusive of 18 and 65 years old), as determined by the date of signing the informed consent form.
• Weight ≥ 70 kg (for males) or ≥ 60 kg (for females), with a BMI ranging from 27.0 to 35.0 kg/m2.
• Resting heart rate ≥ 55 beats per minute and ≤ 90 beats per minute (results of 12-lead electrocardiogram before randomization).
• Self-reported or documented weight change before the screening period of 12 weeks was less than 5.0%, and the participant can maintain their original diet and lifestyle during the trial period.
• Participants must have no pregnancy plans from the time of signing the informed consent form until 4 months after the last dose of the investigational drug.