ClinicalTrials.gg
CompletedNCT07801313Updated Sep 3, 2026

Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers

A Phase 1 interventional study of MWN105 and MWN105 in Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM) and MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Shanghai Minwei Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Shanghai Minwei Biotechnology Co., Ltd (part of Lepu Medical) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Dec 2024, registered Aug 2026).
Phase
Phase 1
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd — 6 open to participants now, 8 under way, 1 of them phase 3. Obesity · Shanghai Minwei Biotechnology Co., Ltd.

Enrollment
11th of 14
55 · median 88
Started
2024
the only one that year
Phase 1
8 of 14
5 open now
Registered
9th of 14
by date

Among the 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd, this one is the 11th largest by enrollment, is the only one that started in 2024, is one of 8 in phase 1, and was the 9th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

Phase 1this study8 · 5 open
Phase 25 · 0 open
Phase 31 · 1 open

By the year they started

First in 2024; this study’s year is marked. 1 started in 2024.

Size and results

Median enrollment 88 across the 14 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd, or all of them as a file.
02

Study summary

This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of MWN105 injection in healthy Chinese volunteers, and to provide a reference for the next clinical trial.

This study includes a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD study consists of 4 dose groups; the MAD study consists of 2 dose groups and adopts a 4-week dose titration scheme.

The study plans to enroll 55 volunteers. The primary endpoint is the incidence of adverse events. The secondary endpoints are the pharmacokinetic and pharmacodynamic characteristics and immunogenicity endpoints.

03

Conditions studied

  • Overweight , Obesity
  • Type 2 Diabetes Mellitus (T2DM)
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

Browse trials for

04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 55 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Shanghai Minwei Biotechnology Co., Ltd is the lead sponsor of 21 studies on the registry; 10 are open to participants now.

First submitted after Shanghai Minwei Biotechnology Co., Ltd became part of Lepu Medical.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The selected subjects should be healthy male or female individuals aged 18 to 45 years (inclusive).
  2. Female subjects should have a body weight of at least 50.0 kg, and male subjects should have a body weight of at least 55.0 kg. Their (BMI) should be within the range of 19.0-28.0 kg/m² (inclusive).
  3. Physical examination, vital signs, 12-lead (ECG), abdominal ultrasound, and clinical laboratory test results (including serum calcitonin, coagulation function, and thyroid function) should show no abnormalities.
  4. Subjects are required to abstain from sexual activity or use two effective methods simultaneously starting from 1 month before screening through 6 months after the last administration, and must have no plans for sperm or egg donation.

Exclusion criteria

Exclusion Criteria:

  1. Any history of clinical severe diseases or current presence of any diseases.
  2. Those with a known history or family history of medullary thyroid carcinoma, type 2 multiple endocrine neoplasia syndrome (MEN2), or those with a history of hypothyroidism or abnormal thyroid hormone levels.
  3. Subjects with a history of acute or chronic pancreatitis, symptomatic gallbladder disease, history of pancreatic injury, or other high-risk factors that may cause pancreatitis, or those with an amylase level > 1.5 times the (ULN) during screening.
  4. Those with clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as having had active ulcers within 6 months), long-term use of drugs that directly affect gastrointestinal motility (including but not limited to mosapride, cispamide), or those who have undergone gastrointestinal surgery within 12 weeks before screening and are assessed by the investigator as not suitable to participate in this clinical study.
  5. Used any prescription drugs, herbal medicines, over-the-counter drugs, or dietary supplements within 2 weeks before administration.
  6. Had an infectious disease within 4 weeks before screening, severe trauma, or a history of major surgery.
  7. Received vaccines or planned to receive vaccines during the trial screening.
  8. Donated blood, experienced significant blood loss (> 450 mL), or received a blood transfusion within 12 weeks before screening.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

06

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    MWN105 S

    MWN105 S consists of 4 dose groups, with doses ranging from 3 mg to 30 mg. Healthy participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN105 or placebo.

    Drug: MWN105 · Drug: Placebo

  • Experimental
    MWN105 M

    MWN105 Cohort M consists of 2 dose groups. In all dose groups, Healthy participants are randomized to receive 4 subcutaneous doses of MWN105 or placebo, administered once weekly.

    Drug: MWN105 · Drug: Placebo

Interventions

  • DrugMWN105

    S1, S2 S3, S4; administered subcutaneously (SC)

  • DrugMWN105

    M1, M2; administered SC

  • DrugPlacebo

    administered SC

07

What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs)

    The incidence of adverse events (AEs) and serious adverse events (SAEs).

    Time frame: From Day 1 to Day 50

Secondary outcomes

  1. Maximum Concentration (Cmax)

    Cmax of MWN105.

    Time frame: From Day 1 to Day 29

  2. Time to Reach Maximum Concentration (Tmax)

    Tmax of MWN105.

    Time frame: From Day 1 to Day 29

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

    AUC0-t of MWN105.

    Time frame: From Day 1 to Day 29

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

    AUC0-inf of MWN105.

    Time frame: From Day 1 to Day 29

  5. Elimination Half-Life (t1/2)

    t1/2 of MWN105.

    Time frame: From Day 1 to Day 29

  6. Steady State Maximum Concentration (Cmax,ss)

    Cmax,ss of MWN105.

    Time frame: From Day 1 to Day 50

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

    Tmax,ss of MWN105.

    Time frame: From Day 1 to Day 50

  8. Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)

    AUC0-t,ss of MWN105.

    Time frame: From Day 1 to Day 50

  9. Steady State Area Under the Curve from time zero to infinity (AUC0-inf,ss)

    AUC0-inf,ss of MWN105.

    Time frame: From Day 1 to Day 50

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

    t1/2,ss of MWN105.

    Time frame: rom Day 1 to Day 50

  11. Change from baseline in body weight over time

    Time frame: Baseline, Day 29, Day 50

  12. Change from baseline in body mass index (BMI) over time

    Time frame: Baseline, Day 29, Day 50

  13. Change from baseline in waist circumference over time

    Time frame: Baseline, Day 29, Day 50

  14. Change from baseline in hip circumference over time

    Time frame: Baseline, Day 29, Day 50

  15. Change from baseline in waist-to-hip ratio over time

    Time frame: Baseline, Day 29, Day 50

  16. Change from baseline in fasting blood glucose over time

    Time frame: Baseline, Day 29, Day 50

  17. Change from baseline in C-peptide over time

    Time frame: Baseline, Day 29, Day 50

  18. Detect anti-drug antibodies (ADA) and their titers

    Time frame: Baseline, Day 29, Day 50

08

Study locations

1 site
  • Hangzhou First People's Hospital
    Hangzhou, Zhejiang, China
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07801313
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Dec 19, 2024
Primary completion
Jul 20, 2025
Completion
Jul 20, 2025
Last update
Sep 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: MWN105

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