ClinicalTrials.gg
CompletedNCT07804810Updated Sep 4, 2026

Phase 2 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity

A Phase 2 interventional study of MWN105 1 and MWN105 2 in Overweight , Obesity, sponsored by Shanghai Minwei Biotechnology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

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 2, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2025, registered Sep 2026).
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetic characteristics, efficacy, and safety of MWN105 Injection in non-diabetic participants with overweight or obesity.

Approximately 120 participants will be randomized to receive different dose levels of MWN105 Injection or matching placebo, administered subcutaneously once weekly for a total treatment duration of 24 weeks, with dose titration from 15 mg to the target dose.

The primary endpoint is the percent change from baseline in body weight at Week 24. Secondary endpoints include changes in body weight and metabolic parameters, bone mineral density, pharmacokinetic parameters, immunogenicity, and safety.

02

Conditions studied

  • Overweight , Obesity

Browse trials for

03

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 120 is above 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 →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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. Male or female participants aged 18 to 65 years (inclusive) at the time of signing the form (ICF).
  2. Body weight ≥ 70 kg (male) or ≥ 60 kg (female), with (BMI) ≥ 30 kg/m² (obesity), or 27 kg/m² ≤ BMI \< 30 kg/m² (overweight) accompanied by at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, prediabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, or polycystic ovary syndrome).
  3. Self-reported or documented diet and exercise control of body weight for 12 weeks or more, with body weight change of less than 5.0% within 12 weeks prior to screening.

Exclusion criteria

Exclusion Criteria:

  1. Known to GLP-1 receptor agonists, any component of the product, or history of severe allergic disease or severe drug allergy.
  2. Use of medications that may affect glucose metabolism or body weight before screening, including antidiabetic drugs, systemic , psychotropic drugs associated with weight change, prescription weight-loss drugs within 12 weeks, or over-the-counter weight-loss drugs/appetite suppressants within 4 weeks.
  3. laboratory abnormalities at screening or before randomization, including:

    1. or AST ≥3 × , or ≥1.5 × ULN.
    2. \<60 mL/min/1.73 m².
    3. \<110 g/L in males or \<100 g/L in females.
    4. Calcitonin ≥35 ng/L.
    5. TSH >6.0 or \<0.4 mIU/L.
    6. Fasting triglycerides ≥5.64 mmol/L.
    7. Amylase or lipase >2 × ULN.
  4. History or presence of clinically significant diseases or conditions that may affect body weight, safety, or study assessments, including:

    1. Secondary or drug-induced overweight/obesity.
    2. Type 1 or type 2 diabetes mellitus, or laboratory evidence of diabetes ( ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or random/2-hour OGTT plasma glucose ≥11.1 mmol/L).
    3. Acute or chronic pancreatitis or pancreatic injury.
    4. Gallstones or cholecystitis, except adequately treated cases without residual disease.
    5. Medullary thyroid carcinoma, MEN 2A/2B, or relevant family history.
    6. Previous bariatric surgery or planned procedures that may significantly affect body weight.
    7. Moderate or severe depression, PHQ-9 score ≥15, severe psychiatric disorders, suicidal ideation/behavior, or suicide risk.
    8. within 5 years, except specified adequately treated localized cancers.
    9. Significant cardiovascular or cerebrovascular disease within 6 months before screening/randomization.
    10. Osteoporosis defined as T-score ≤-2.5 or Z-score ≤-2.0, as applicable.
    11. Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg).
    12. Clinically significant thyroid dysfunction.
    13. Significant gastric emptying disorders or active gastrointestinal disease.
    14. History of organ transplantation or awaiting transplantation.
    15. diseases likely to require systemic glucocorticoids.
    16. Current participation in an active weight-loss program not yet in the maintenance phase.
Terms in these criteria, in plain language(14)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

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.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    MWN105 Cohort 1

    Drug: MWN105 1

  • Experimental
    MWN105 Cohort 2

    Drug: MWN105 2

  • Experimental
    MWN105 Cohort 3

    Drug: MWN105 3

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Administered SC, QW, 24 weeks

  • Administered SC, QW, 24 weeks

  • Administered SC, QW, 24 weeks

  • DrugPlacebo

    Administered SC, QW, 24 weeks

06

What researchers measure

Primary outcomes

  1. Percentage Change from Baseline in Body Weight at Week 24.

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Change from baseline in body weight over time

    Change in body weight from baseline throughout the study.

    Time frame: up to 24 weeks

  2. Proportion of Participants Achieving ≥5% Body Weight Reduction from Baseline at Week 24

    Time frame: Baseline, Week 24

  3. Proportion of Participants Achieving ≥10% Body Weight Reduction from Baseline at Week 24

    Time frame: Baseline, Week 24

  4. Proportion of Participants Achieving ≥15% Body Weight Reduction from Baseline at Week 24

    Time frame: Baseline, Week 24

  5. Proportion of Participants Achieving ≥20% Body Weight Reduction from Baseline at Week 24

    Time frame: Baseline, Week 24

  6. Change from baseline in lipid profile over time

    Change in lipid parameters (including total cholesterol, LDL-C, HDL-C, triglycerides) from baseline throughout the study.

    Time frame: up to 24 weeks

  7. Change from baseline in fasting plasma glucose (FPG) over time

    Change in fasting plasma glucose levels from baseline throughout the study.

    Time frame: up to 24 weeks

  8. Change from baseline in glycated hemoglobin (HbA1c) over time

    Change in HbA1c levels from baseline throughout the study.

    Time frame: up to 24 weeks

  9. Change from baseline in adiponectin over time

    Change in adiponectin levels from baseline throughout the study.

    Time frame: up to 24 weeks

  10. Change from baseline in alanine aminotransferase (ALT) over time[

    Change in ALT levels from baseline throughout the study.

    Time frame: up to 24 weeks

  11. Change from baseline in aspartate Aminotransferase (AST) over time

    Change in ALT levels from baseline throughout the study.

    Time frame: up to 24 weeks

  12. Change from baseline in serum uric acid over time

    Change in serum uric acid levels from baseline throughout the study.

    Time frame: up to 24 weeks

  13. Change from Baseline in Liver Fat Content (LFC) at Week 24

    Change in LFC from baseline to Week 24.

    Time frame: Baseline, Week 24

  14. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Number and proportion of participants with treatment-emergent adverse events throughout the study.

    Time frame: up to 24 weeks

07

Study locations

1 site
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2025 to primary completion in Mar 2026, 6 months.

Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's 6 months is below that.

Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 4, 2026
StartActual
Sep 3, 2025
Primary completionActual
Mar 21, 2026
CompletionActual
Apr 16, 2026
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07804810
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Sep 3, 2025
Primary completion
Mar 21, 2026
Completion
Apr 16, 2026
Last update
Sep 4, 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 Sep 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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