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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study to Evaluate MWN109 Tablets in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Tablets in Healthy Adult Participants

A Study to Evaluate MWN109 Tablets in Healthy Adult Participants (NCT06938269) is a Phase 1 interventional studying Overweight or Obesity, sponsored by Shanghai Minwei Biotechnology Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a Phase 1, randomized, double-blind, placebo-controlled, single-and-multiple ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of orally administered MWN109 tablets will be assessed in healthy adult participants.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Overweight or Obesity, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Overweight or Obesity subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Males or females aged 18 to 60 years (inclusive) at the time of signing the willing to sign a consent form (Caucasians should be no less than 80% since the implementation of Protocol Clarification Letter #2, dated 02 Sep 2025). 2. \[Part A: SAD\] Body mass index (BMI) of 19.0 to 40.0 kg/m2 (inclusive) with body weight \> 65.0 kg and \<130.0 kg. \[Part B: MAD\] BMI of 27.0 to 45.0 kg/m2 (inclusive) with body weight \> 65.0 kg and \<130.0 kg. 3. Stable body weight within 3 months before screening (defined as self-reported change \< 5%). 4. Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening. If the heart rate is \> 90 or \< 45 bpm, it is to be repeated 2 more times (separated by at least 2 min) and the average of the 3 heart rate values is to be used to determine the participant's eligibility. 5. Females of childbearing potential and males who are not surgically sterile (\>180 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 4 months after the last administration, OR females of non-reproductive potential as defined below: - Postmenopausal as defined as: - No menses for at least 12 months; OR - No menses for at least 12 months AND with a follicle-stimulating hormone level \> 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR - History of hysterectomy; OR - History of bilateral oophorectomy 6. Male participants must agree to refrain from sperm donation and females should refrain from ova donation from Screening until 4 months after the last administration. 7. Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 h before each blood sample collection for the clinical laboratory analysis, which should not be strenuous, and willing to be restrained from alcohol and smoking during the study period. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Males or females aged 18 to 60 years (inclusive) at the time of signing the informed consent (Caucasians should be no less than 80% since the implementation of Protocol Clarification Letter #2, dated 02 Sep 2025). 2. \[Part A: SAD\] Body mass index (BMI) of 19.0 to 40.0 kg/m2 (inclusive) with body weight \> 65.0 kg and \<130.0 kg. \[Part B: MAD\] BMI of 27.0 to 45.0 kg/m2 (inclusive) with body weight \> 65.0 kg and \<130.0 kg. 3. Stable body weight within 3 months before screening (defined as self-reported change \< 5%). 4. Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening. If the heart rate is \> 90 or \< 45 bpm, it is to be repeated 2 more times (separated by at least 2 min) and the average of the 3 heart rate values is to be used to determine the participant's eligibility. 5. Females of childbearing potential and males who are not surgically sterile (\>180 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 4 months after the last administration, OR females of non-reproductive potential as defined below: * Postmenopausal as defined as: * No menses for at least 12 months; OR * No menses for at least 12 months AND with a follicle-stimulating hormone level \> 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR * History of hysterectomy; OR * History of bilateral oophorectomy 6. Male participants must agree to refrain from sperm donation and females should refrain from ova donation from Screening until 4 months after the last administration. 7. Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 h before each blood sample collection for the clinical laboratory analysis, which should not be strenuous, and willing to be restrained from alcohol and smoking during the study period. 8. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by all study requirements and restrictions. Exclusion Criteria: 1. 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 Principal Investigator (or delegate). 2. Screening blood pressure in supine outside the ranges 90-159 mmHg systolic, 50-95 mmHg diastolic. If abnormal blood pressure is observed, the blood pressure is to be repeated 2 more times, and the average of the 3 blood pressure values is to be used to determine the participant eligibility. 3. 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. 4. History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection. 5. Any of the following: 1. QTcF \> 450 msec confirmed by repeat measurement; 2. QRS duration \> 120 msec confirmed by repeat measurement; 3. PR interval \> 220 msec confirmed by repeat measurement. Notes: Regarding a), b) and c), ECG is to be repeated 2 more times when out-of-range and the average of the values is to be used to determine the participant eligibility; 4. Findings which would make QTc measurements difficult or QTc data uninterpretable; 5. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome). 6. Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality. 7. History of diabetes mellitus or clinical evidence of diabetes (e.g., hemoglobin A1c ≥ 6.5%, fasting plasma glucose ≥ 126 mg/dL \[7.0 mmol/L\]) at Screening, non-fasting plasma 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. 8. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis. 9. With any of following laboratory abnormality at screening and confirmed by a single repeat at the discretion of the Principal Investigator (or delegate): a) Elevation in serum amylase or lipase (\> 1.5 × upper limit of normal \[ULN\]). b) Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 1.5 × ULN or total bilirubin \>1.5 × ULN. c) Have serum triglycerides (TG) ≥ 5.65 mmol/L (500 mg/dL) at Screening. d) Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73m2 by Cockcroft-Gault equation as below: (140 - age) × mass (kg)/72 × creatinine (mg/dL); multiply by 0.85 if female. 10. Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone \> 6 mIU/L or \< 0.4 mIU/L. 11. History of clinically significant (in the opinion of the Principal Investigator or delegate) abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease). 12. Presence of clinically significant acute gastrointestinal symptoms (e.g., nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the Principal Investigator (or delegate). 13. Any history or plan of gastrointestinal surgery excluding appendectomy. 14. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies. 15. 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. 16. History of alcoholism or drug/chemical abuse within 1 year prior to D-1. 17. Alcohol consumption of \> 21 units per week for males and \> 14 units per week for females, on average. One unit of alcohol equals 1/2 pint (285 mL) of beer, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits. 18. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) during the Screening period. 19. Daily use of more than 10 cigarettes/day (on average), or 2 cigars/day (on average), or equivalent use of any nicotine-containing product within 6 weeks prior to Screening. 20. Participant is unwilling to refrain from strenuous exercise (e.g., heavy lifting, weight training, and aerobics) for 72 h prior to each blood collection for clinical laboratory tests. 21. Females of pregnant or lactating, or those with a positive pregnancy test at Screening. 22. Intolerance to venipuncture for blood sampling or history of fainting at blood drawing or sight of blood, unless deemed acceptable by the Principal Investigator (or delegate). 23. 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 Principal Investigator (or delegate). 24. History of severe Types I-IV hypersensitivity reactions, anaphylaxis, cytokine release syndrome, atopic individuals, or allergic reactions to multiple drugs. If the Principal Investigator (or delegate) is considering enrolling a participant with multiple drug allergies, agreement with the Medical Monitor should be sought. 25. History of or suspected allergy or hypersensitivity to the IP or its components. 26. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Principal Investigator (or delegate)and agreement with the Sponsor. 27. Use or intend to use slow-release medications/products considered to still be active within 14 days prior to D-1, unless deemed acceptable by the Principal Investigator (or delegate). 28. Use of any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to D-1 or during the study, unless deemed acceptable by the Principal Investigator (or delegate) and agreement with Sponsor, with the exception of paracetamol/acetaminophen (maximum 2 g per day for up to 3 days) and topically applied medications which is permitted up to 48 h prior to dosing. 29. Participants with a history of infectious diseases (which may affect the ability of the participant to participate in the study at the discretion of the Principal Investigator or delegate), severe trauma, or major surgical operation within 4 weeks prior to Screening. 30. Have been vaccinated within 4 weeks prior to Screening or plan to have vaccination during the study. 31. Donation of blood or massive blood loss (\> 450 mL) OR receipt of blood products within 12 weeks prior to Screening, plasma from 2 weeks prior to Screening, and platelets from 6 weeks prior to Screening. 32. Participation in a clinical study involving administration of an investigational agent/device or vaccine (new chemical entity) within 30 days or 5 half-lives, or having received a biological product within 12 weeks prior to Screening. 33. Poor peripheral venous access. 34. Are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 35. The presence of clinically significant physical examination, vital sign, drug, or ECG findings at Screening or baseline or laboratory findings at Screening that, in the opinion of the Principal Investigator (or delegate) or Medical Monitor, may interfere with any aspect of study conduct or interpretation of results. 36. Are deemed unsuitable by the Principal Investigator (or delegate) for any other reason.

Treatments Being Tested

DRUG

MWN109 tablet

Strength: 4mg, 7.5mg, 15mg, 30mg, and 45 mg; Administration: Oral.

DRUG

Placebo

Administration: Oral.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

CMAX Clinical Research
Adelaide, South Australia, Australia
Veritus Research
Bayswater, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06938269), the sponsor (Shanghai Minwei Biotechnology Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06938269 clinical trial studying?

This is a Phase 1, randomized, double-blind, placebo-controlled, single-and-multiple ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of orally administered MWN109 tablets will be assessed in healthy adult participants. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06938269?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06938269?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06938269. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06938269. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.