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Delfa

← All trials/NCT07787611

CompletedPhase 1

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

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

NCT IDNCT07787611
Org study IDMWN109 Oral-I

Timeline

Milestones

Study start2025-06-27actual
Primary completion2025-12-20actual
Study completion2025-12-20actual
Study first posted2026-08-26actual
Last update posted2026-08-26actual

Assets

Investigational agents

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersAccepted

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:

a)fasting blood glucose ≥ 7.0 mmol/L or < 3.9 mmol/L, or HbA1c > 6.5%;
b)estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m²;
c)triglycerides (TG) ≥ 5.65 mmol/L.

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
Other (unclassified)
2

Safety / tolerability / PK

11 endpoints
Primary/protocol endpoint

Incidence of adverse events (AEs)

Time frame:From Day 1 to Day 42

event count, event

Secondary/protocol endpoint

Maximum Concentration (Cmax)

Time frame:From Day 1 to Day 15

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Concentration (Tmax)

Time frame:From Day 1 to Day 15

time to event, event

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 15

descriptive

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 15

descriptive

Secondary/protocol endpoint

Elimination Half-Life (t1/2)

Time frame:From Day 1 to Day 15

concentration, descriptive

Secondary/protocol endpoint

Steady State Maximum Concentration (Cmax,ss)

Time frame:From Day 1 to Day 42

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Concentration at Steady State (Tmax,ss)

Time frame:From Day 1 to Day 42

time to event, event

Secondary/protocol endpoint

Steady State Apparent Terminal Elimination Half-life (t1/2,ss)

Time frame:From Day 1 to Day 42

concentration, descriptive

Secondary/protocol endpoint

Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)

Time frame:From Day 1 to Day 42

concentration, descriptive

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint/low confidence

Steady State Minimum Concentration (Cmin,ss)

Time frame:From Day 1 to Day 42

concentration, descriptive

Secondary/protocol endpoint/low confidence

Steady State Concentration (Cav,ss)

Time frame:From Day 1 to Day 42

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.