A Study to Evaluate Different Administration Conditions and the Food Effect of MWN109 Tablets in Chinese Participants

NCT07801326 | Completed Phase 1

• 1 other identifier: MWN109-Oral-I-EPK
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, multiple-dose study to evaluate the effects of different volumes of administration water, post-dose fasting duration, and high-fat diet on the pharmacokinetics of the 15 mg dose of MWN109 tablets in adult Chinese participants, as well as to assess its safety, tolerability, and immunogenicity. The study consists of two parts. Part 1 is an administration condition study, which includes 6 groups stratified by post-dose fasting duration and administration water volume. Part 2 is a food-effect study, comprising 3 groups stratified by dietary conditions.. A total of 162 participants are planned to be enrolled. The primary endpoint is pharmacokinetics (PK). PK parameters include Cmax, Cmin, AUC0-t, AUC0-∞, Tmax, and t1/2. Secondary endpoints include safety (adverse events \[AEs\] and serious adverse events \[SAEs\]) and immunogenicity (anti-drug antibodies \[ADAs\]).

Conditions

Type 2 Diabetes Mellitus (T2DM); Overweight , Obesity

Outcome Measures

Primary Outcomes (6)

• Maximum Concentration (Cmax)

  Cmax of MWN109.

  From Day 1 to Day 29

• Minimum Concentration (Cmin)

  Cmin of MWN109.

  From Day 1 to Day 29

• Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)

  AUC0-t of MWN109.

  From Day 1 to Day 29

• Area Under the Curve From Time 0 to Infinity (AUC0-inf)

  AUC0-inf of MWN109.

  From Day 1 to Day 29

• Time to Reach Maximum Concentration (Tmax)

  Tmax of MWN109.

  From Day 1 to Day 29

• Elimination Half-Life (t1/2)

  t1/2 of MWN109.

  From Day 1 to Day 29

Secondary Outcomes (2)

• Incidence of adverse events (AEs)

  From Day 1 to Day 29

• Anti-Drug Antibody (ADA)

  From Day 1 to Day 29

Study Arms (2)

Part 1

EXPERIMENTAL

Participants receive oral MWN109 tablets under varying conditions of administration water volume and post-dose feeding time.

Drug: MWN109 Tablets

Part 2

EXPERIMENTAL

Participants take oral MWN109 tablets under three conditions: fasted state, fed state, or feeding after drug administration.

Drug: MWN109 Tablets

Interventions

MWN109 Tablets DRUG

administered orally

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants aged 18 to 50 years, inclusive, at the time of signing the informed consent form.
• Body mass index (BMI) = weight (kg) / height squared (m²): 19.0 kg/m² ≤ BMI \< 30.0 kg/m², with a body weight ≥ 55 kg for males or ≥ 50 kg for females.

You may not qualify if:

• History of severe drug allergy (especially known or suspected allergy to any component or excipient of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution.
• History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis.
• History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; history of thyroid insufficiency or abnormal thyroid hormone levels.
• Gastrointestinal diseases at present or at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction), severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months), previous gastric resection surgery, or gastrointestinal clinical symptoms or signs at screening (e.g., diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating diarrhea and constipation) (diarrhea is defined as watery stools and/or ≥ 3 bowel movements per day; constipation is defined as the inability to achieve a bowel movement at least every other day).
• History of any of the following cardiac diseases within 6 months prior to screening: decompensated cardiac insufficiency (New York Heart Association \[NYHA\] class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation.
• Hemorrhagic or ischemic stroke within 6 months prior to screening, if judged by the investigator to be unsuitable for participation in this clinical trial.
• Severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) within 6 months prior to screening (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration).
• Any laboratory finding at screening meeting any of the following criteria:
• glycated hemoglobin (HbA1c) ≥ 6.5%, or fasting blood glucose (GLU) \> 6.1 mmol/L or \< 3.9 mmol/L.
• alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) \> 1.5 times the upper limit of normal (ULN).
• serum creatinine (CR) \> 1.1 times ULN, or estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m2 (CKD-EPI formula), or urine protein (PRO) positive (1+) or above.
• serum uric acid (UA) \> 540 μmol/L.
• serum calcitonin (PCT) ≥ 35 ng/L.
• thyroid-stimulating hormone (TSH) \> 6.0 mIU/L or below the lower limit of normal (LLN).
• fasting triglycerides (TG) ≥ 3.42 mmol/L.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: May 24, 2026
• Primary Completion: August 10, 2026
• Study Completion: August 10, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)