Overweight , ObesityPhase 1NCT07801313
Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers
A Phase 1 study testing MWN105 in people with Overweight , Obesity and Type 2 Diabetes Mellitus (T2DM), run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- MWN105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to 20 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The selected subjects should be healthy male or female individuals aged 18 to 45 years (inclusive).
- 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 body mass index (BMI) should be within the range of 19.0-28.0 kg/m² (inclusive).
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), abdominal ultrasound, and clinical laboratory test results (including serum calcitonin, coagulation function, and thyroid function) should show no clinically significant abnormalities.
- Subjects are required to abstain from sexual activity or use two effective contraceptive 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.
Who cannot join
- Any history of clinical severe diseases or current presence of any clinically significant diseases.
- 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.
- 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 upper limit of the normal range (ULN) during screening.
- 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.
- Used any prescription drugs, herbal medicines, over-the-counter drugs, or dietary supplements within 2 weeks before administration.
- Had an infectious disease within 4 weeks before screening, severe trauma, or a history of major surgery.
- Received vaccines or planned to receive vaccines during the trial screening.
- Donated blood, experienced significant blood loss (> 450 mL), or received a blood transfusion within 12 weeks before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Ascending Doses of MWN105 Injection in Healthy Chinese Volunteers
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.
- Conditions
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Being tested
- MWN105, Placebo
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN105Drug
S1, S2 S3, S4; administered subcutaneously (SC)
MWN105Drug
M1, M2; administered SC
PlaceboDrug
administered SC
| Study group | Role | What they receive |
|---|---|---|
| MWN105 S | Experimental | 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. Receives: Drug: MWN105; Drug: Placebo |
| MWN105 M | Experimental | 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. Receives: Drug: MWN105; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
The incidence of adverse events (AEs) and serious adverse events (SAEs).
Measured: From Day 1 to Day 50
Secondary outcomes (18)
Maximum Concentration (Cmax)
Cmax of MWN105.
Measured: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN105.
Measured: From Day 1 to Day 29
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN105.
Measured: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN105.
Measured: From Day 1 to Day 29
Elimination Half-Life (t1/2)
t1/2 of MWN105.
Measured: From Day 1 to Day 29
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN105.
Measured: From Day 1 to Day 50
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN105.
Measured: From Day 1 to Day 50
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN105.
Measured: From Day 1 to Day 50
Steady State Area Under the Curve from time zero to infinity (AUC0-inf,ss)
AUC0-inf,ss of MWN105.
Measured: From Day 1 to Day 50
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN105.
Measured: rom Day 1 to Day 50
Change from baseline in body weight over time
Measured: Baseline, Day 29, Day 50
Change from baseline in body mass index (BMI) over time
Measured: Baseline, Day 29, Day 50
Change from baseline in waist circumference over time
Measured: Baseline, Day 29, Day 50
Change from baseline in hip circumference over time
Measured: Baseline, Day 29, Day 50
Change from baseline in waist-to-hip ratio over time
Measured: Baseline, Day 29, Day 50
Change from baseline in fasting blood glucose over time
Measured: Baseline, Day 29, Day 50
Change from baseline in C-peptide over time
Measured: Baseline, Day 29, Day 50
Detect anti-drug antibodies (ADA) and their titers
Measured: Baseline, Day 29, Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start19 Dec 2024
- Primary completion20 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801313
- Sponsor's protocol ID
- MWN105-I
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Ascending Doses of MWN105 Injection in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT07801313
- Acronym / sponsor ID
- MWN105-I
- Conditions
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWN105 S | Experimental | Drug: MWN105, Drug: PlaceboMWN105 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. |
| MWN105 M | Experimental | Drug: MWN105, Drug: PlaceboMWN105 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The selected subjects should be healthy male or female individuals aged 18 to 45 years (inclusive).
- 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 body mass index (BMI) should be within the range of 19.0-28.0 kg/m² (inclusive).
- Physical examination, vital signs, 12-lead electrocardiogram (ECG), abdominal ultrasound, and clinical laboratory test results (including serum calcitonin, coagulation function, and thyroid function) should show no clinically significant abnormalities.
- Subjects are required to abstain from sexual activity or use two effective contraceptive 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.
Key exclusion criteria (8 listed)
- Any history of clinical severe diseases or current presence of any clinically significant diseases.
- 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.
- 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 upper limit of the normal range (ULN) during screening.
- 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.
- Used any prescription drugs, herbal medicines, over-the-counter drugs, or dietary supplements within 2 weeks before administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MWN105S1, S2 S3, S4; administered subcutaneously (SC) | Drug | MWN105 S |
| MWN105M1, M2; administered SC | Drug | MWN105 M |
| Placeboadministered SC | Drug | MWN105 M, MWN105 S |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From Day 1 to Day 50
The incidence of adverse events (AEs) and serious adverse events (SAEs).
18 secondary outcomes
Maximum Concentration (Cmax)
Time frame: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: From Day 1 to Day 29
Elimination Half-Life (t1/2)
Time frame: From Day 1 to Day 29
Steady State Maximum Concentration (Cmax,ss)
Time frame: From Day 1 to Day 50
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame: From Day 1 to Day 50
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
Time frame: From Day 1 to Day 50
Steady State Area Under the Curve from time zero to infinity (AUC0-inf,ss)
Time frame: From Day 1 to Day 50
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame: rom Day 1 to Day 50
Change from baseline in body weight over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in body mass index (BMI) over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in waist circumference over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in hip circumference over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in waist-to-hip ratio over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in fasting blood glucose over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in C-peptide over time
Time frame: Baseline, Day 29, Day 50
Detect anti-drug antibodies (ADA) and their titers
Time frame: Baseline, Day 29, Day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MWN105 in people with Overweight , Obesity and Type 2 Diabetes Mellitus (T2DM), run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: From Day 1 to Day 50). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.