Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Meal Timing Effects Following Single and Multiple Oral Administration of MWN109 Tablets in Chinese Study Participants
Lead sponsor
Asset
MWN109
Oral · GLP-1 / GIP / glucagon triple
Listed sites
1
Recruiting sites
-
Actual enrollment
98
Study population
Healthy volunteers
Eligibility highlights
•BMI 19-29.9
Primary endpoint
•Adverse events (AEs)
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male or female participants aged 18 to 50 years (inclusive at the time of signing the informed consent form).
2. Body mass index (BMI) = weight (kg) / height squared (m²): SAD part: 19.0 to 29.9 kg/m² (inclusive), with body weight ≥ 55 kg (male) or ≥ 50 kg (female); MAD part: 24.0 to 37.5 kg/m² (inclusive), with body weight ≥ 70 kg (male) or ≥ 60 kg (female).
3. Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization.
Exclusion criteria
1. History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution.
2. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis, or amylase or lipase > 1.5 times the upper limit of normal (ULN) at screening.
3. Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels.
4. Gastrointestinal diseases present at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction) or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months).
5. History of infectious disease within 4 weeks prior to screening (which, in the investigator's judgment, may significantly affect the safety evaluation of the participant), or severe trauma or major surgery within 3 months.
6. History of severe arrhythmia prior to screening judged by the investigator as unsuitable for participation in this study.
7. Any of the following abnormal laboratory findings at screening:
8. Blood donation, significant blood loss (> 400 mL), or receipt of blood transfusion within 3 months prior to screening.
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
11 endpointsIncidence of adverse events (AEs)
Time frame:From Day 1 to Day 42
event count, event
Maximum Concentration (Cmax)
Time frame:From Day 1 to Day 15
concentration, descriptive
Time to Reach Maximum Concentration (Tmax)
Time frame:From Day 1 to Day 15
time to event, event
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame:From Day 1 to Day 15
descriptive
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame:From Day 1 to Day 15
descriptive
Elimination Half-Life (t1/2)
Time frame:From Day 1 to Day 15
concentration, descriptive
Steady State Maximum Concentration (Cmax,ss)
Time frame:From Day 1 to Day 42
concentration, descriptive
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame:From Day 1 to Day 42
time to event, event
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame:From Day 1 to Day 42
concentration, descriptive
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
Time frame:From Day 1 to Day 42
concentration, descriptive
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
Time frame:From Day 1 to Day 42
descriptive
Other (unclassified)
2 endpointsSteady State Minimum Concentration (Cmin,ss)
Time frame:From Day 1 to Day 42
concentration, descriptive
Steady State Concentration (Cav,ss)
Time frame:From Day 1 to Day 42
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.