A Study to Evaluate MWN109 Injection in Healthy Subjects
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Overweight or Obese
In brief
This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.
Key facts
- Study ID
- NCT06859853
- Run by
- Shanghai Minwei Biotechnology Co., Ltd
- People needed
- 72
- Starts
- 2025-03-17
- Expected to finish
- 2025-11-25
- Last updated by the study team
- 2025-04-15
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.
- [Part A: SAD] BMI of 19.0 to 40.0 kg/m2 (inclusive). [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kg for males.
- History of stable body weight for 3 months (defined as change < 5%).
- Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
- Females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
- Male participants must agree to refrain from sperm donation and females should refrain from ova donation from D-1 until 4 months after the last administration.
- Able to comprehend and willing to sign an ICF and to abide by all study requirements and restrictions.
You may not qualify if…
- Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric, disorders as determined by the investigator (or designee).
- History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
- History of insulinoma or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months prior to Screening.
- History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
- Any of the following:
- QTcF > 450 msec regardless of gender , confirmed by repeat measurement.
- QRS duration > 110 msec confirmed by repeat measurement.
- PR interval > 220 msec confirmed by repeat measurement.
- Findings which would make QTc measurements difficult or QTc data uninterpretable.
- History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality.
- History of diabetes mellitus Type I or II or clinical evidence of diabetes (e.g., hemoglobin A1c ≥ 6.5%, fasting blood glucose ≥ 126 mg/dL [7.0 mmol/L]) at Screening, non-fasting glucose ≥ 200 mg/dL (11.1 mmol/L) at Screening, or use of any hypoglycemic drugs during Screening or within 3 months prior to Screening
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis.
- With any of following laboratory abnormality:
- Elevation in serum amylase or lipase (> 1.5 × upper limit of normal [ULN]).
- Have serum AST or ALT > 2 × ULN or total bilirubin >1.5 × ULN.
- Have serum TG ≥ 5.65 mmol/L (500 mg/dL) at screening
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2.
- History of clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), severe chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or uncontrolled gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease).
- Long-term use of drugs directly affecting the gastrointestinal motility (including but not limited to mosapride, cisapride) or gastrointestinal surgery within 12 weeks prior to Screening and are inappropriate for participation in this clinical study as assessed by the Investigator.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies and p24 antigen.
- Any history of severe psychiatric disorder such as major depressive disorder, bipolar disorder, and schizophrenia, or history of suicidal ideation, behavior or attempts or other psychiatric disorder (within 2 years of Screening).
- Any suicidal ideation as identified by endorsement of (answered yes to) any of the items numbered 1-5 on the Columbia Suicide Severity Rating Scale (C-SSRS), if applicable.
- History of alcoholism or drug/chemical abuse within 1 year prior to D-1.
- Alcohol consumption of > 21 units per week for males and > 14 units per week for females, on average. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
Where it is running
- Veritus Research — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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