A Study to Evaluate MWN109 Tablets in Healthy Adult Participants

NCT06938269 | Recruiting Phase 1 DMC

• 1 other identifier: MWN109-T-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (6)

• Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• Number of participants with change in laboratory parameters following treatment administration

  Clinical safety laboratory measures include urine drug screening, alcohol breath test, serum virology, pregnancy test, chemistry, hematology, urinalysis and thyroid function.

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• Number of participants with change in 12-lead ECG following treatment administration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• Number of participants with change in Vital signs following treatment administration

  Vital signs including pulse rate, respiratory rate, supine blood pressure and tympanic body temperature.

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• Incidence of anti-drug antibody (ADA) formation following treatment administration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• Number of participants with change in physical examinations following treatment administration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

Secondary Outcomes (10)

• PK parameters- Cmax: maximum observed concentration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• PK parameters- Tmax: time to reach maximum concentration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• PK parameters- t1/2: half-life

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• PK parameters- AUC0-inf: area under the concentration-time curve from time zero to the theoretical infinite time

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

• PK parameters- AUC0-t: area under the concentration-time curve from time zero to the time of the last quantifiable concentration

  SAD: Up to Day 22; MAD: Up to Day 56 (Cohorts B1 and B2) or Day 58 (Cohort B3) post first dose administration

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants in SAD cohorts will be randomized to receive a single dose of MWN109 tablet or placebo across 4 cohorts. Participants in MAD cohorts will be randomized to receive MWN109 tablet or placebo once daily for 28 days in cohorts B1 and B2, 30 days in cohort B3.

Drug: Placebo

MWN109 tablets

ACTIVE COMPARATOR

Participants in SAD cohorts will be randomized to receive a single dose of MWN109 tablet or placebo across 4 cohorts. Planned dosage per cohorts are A1:7.5mg, A2:15mg, A3:30mg, A4:45mg. Participants in MAD cohorts will be randomized to receive MWN109 tablet or placebo once daily for a total of 28 days in cohorts B1 and B2, 30 days in cohort B3. Initiation and dose levels of MAD cohorts will be determined in the safety review and dose escalation meeting by the Safety Review Committee based on the review of safety, tolerability, and PK data from SAD part. The target doses could be 15mg, 30mg and 45 mg.

Drug: MWN109 tablet

Interventions

MWN109 tablet DRUG

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

MWN109 tablets

Placebo DRUG

Administration: Oral.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• \[Part A: SAD\] 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.
• Stable body weight within 3 months before screening (defined as self-reported change \< 5%).
• 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.
• 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
• 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.
• 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.
• Able to comprehend and willing to sign an informed consent form (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 Principal Investigator (or delegate).
• 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.
• 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 confirmed by repeat measurement;
• QRS duration \> 120 msec confirmed by repeat measurement;
• 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;
• 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 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.
• 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 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.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (2)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

RECRUITING

Veritus Research

Bayswater, Victoria, 3153, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Fu

CONTACT

86 13107731990; fuyang@minweibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: June 18, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)