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Delfa

← All trials/NCT07787624

CompletedPhase 1

Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers

A Randomized, Double-Blind, Placebo-Controlled Phase 1a Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Dose Escalation of MWN109 Injection in Healthy Chinese Volunteers

Asset

MWN109

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

1

Recruiting sites

-

Actual enrollment

48

Study population

Healthy volunteers

Eligibility highlights

•BMI 19-28

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 IDNCT07787624
Org study IDMWN109-Ia

Timeline

Milestones

Study start2024-12-18actual
Primary completion2025-07-20actual
Study completion2025-07-20actual
Study first posted2026-08-26actual
Last update posted2026-10-28actual

Assets

Investigational agents

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Male or female participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1/3.

2. Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 19.0 to 28.0 kg/m^2 (inclusive).

3. From the time of signing the informed consent form (ICF) until 3 months after the last dose, participants must have no plans to become pregnant or to father a child, must agree to use effective contraceptive measures to prevent pregnancy or causing a partner to become pregnant, and must have no plans to donate sperm or eggs.

Exclusion criteria

1. History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 Injection) or severe atopic allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or severe allergic constitution (allergy to two or more foods or drugs) (by inquiry).

2. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury or other high-risk factors that may lead to pancreatitis, or serum amylase > 1.5 × upper limit of normal (ULN) at screening (by inquiry and examination).

3. Family history or history of medullary thyroid C-cell tumor/carcinoma; history of thyroid dysfunction or abnormal thyroid hormone levels (by inquiry).

4. History or presence at screening of digestive system diseases that may increase the risk to volunteers, such as pancreatitis, abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction, etc.), or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months) (by inquiry).

5. History of infectious diseases (which, in the investigator's assessment, may significantly affect the safety evaluation of volunteers) or severe trauma within 4 weeks before screening, or major surgery within 3 months before screening (by inquiry and examination).

6. Use of any prescription or over-the-counter drug (including chemical drugs, vitamins, herbal medicines, etc.) within 2 weeks before dosing (by inquiry and examination);

7. History of substance abuse (by inquiry).

8. Blood donation or massive blood loss (> 400 mL) or blood transfusion within 3 months before screening (by inquiry).

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 43

event count, event

Secondary/protocol endpoint

Maximum Concentration (Cmax)

Time frame:From Day 1 to Day 29

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Concentration (Tmax)

Time frame:From Day 1 to Day 29

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 29

descriptive

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 29

descriptive

Secondary/protocol endpoint

Elimination Half-Life (t1/2)

Time frame:From Day 1 to Day 29

concentration, descriptive

Secondary/protocol endpoint

Steady State Maximum Concentration (Cmax,ss)

Time frame:From Day 1 to Day 43

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 43

time to event, event

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 43

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From Day 1 to Day 43

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 43

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Steady State Minimum Concentration (Cmin,ss)

Time frame:From Day 1 to Day 43

concentration, descriptive

Secondary/protocol endpoint/low confidence

Steady State Concentration (Cav,ss)

Time frame:From Day 1 to Day 43

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.