Overweight or ObesePhase 1NCT06859853
A Study to Evaluate MWN109 Injection in Healthy Subjects
A Phase 1 study testing Subcutaneous single and mutiple dose in people with Overweight or Obese, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in Australia.
Trial summary
This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obese
- What is being tested?
- Subcutaneous single and mutiple dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Mar 2025to 25 Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.
- [Part A: SAD] BMI of 19.0 to 40.0 kg/m2 (inclusive). [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kg for males.
- History of stable body weight for 3 months (defined as change < 5%).
- Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
- Females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
- Male participants must agree to refrain from sperm donation and females should refrain from ova donation from D-1 until 4 months after the last administration.
- Able to comprehend and willing to sign an ICF and to abide by all study requirements and restrictions.
Who cannot join
- Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric, disorders as determined by the investigator (or designee).
- History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
- History of insulinoma or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months prior to Screening.
- History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
- Any of the following:
- QTcF > 450 msec regardless of gender , confirmed by repeat measurement.
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- QRS duration > 110 msec confirmed by repeat measurement.
- PR interval > 220 msec confirmed by repeat measurement.
- Findings which would make QTc measurements difficult or QTc data uninterpretable.
- History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
- Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality.
- History of diabetes mellitus Type I or II or clinical evidence of diabetes (e.g., hemoglobin A1c ≥ 6.5%, fasting blood glucose ≥ 126 mg/dL [7.0 mmol/L]) at Screening, non-fasting glucose ≥ 200 mg/dL (11.1 mmol/L) at Screening, or use of any hypoglycemic drugs during Screening or within 3 months prior to Screening
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis.
- With any of following laboratory abnormality:
- Elevation in serum amylase or lipase (> 1.5 × upper limit of normal [ULN]).
- Have serum AST or ALT > 2 × ULN or total bilirubin >1.5 × ULN.
- Have serum TG ≥ 5.65 mmol/L (500 mg/dL) at screening
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2.
- History of clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), severe chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or uncontrolled gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease).
- Long-term use of drugs directly affecting the gastrointestinal motility (including but not limited to mosapride, cisapride) or gastrointestinal surgery within 12 weeks prior to Screening and are inappropriate for participation in this clinical study as assessed by the Investigator.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies and p24 antigen.
- Any history of severe psychiatric disorder such as major depressive disorder, bipolar disorder, and schizophrenia, or history of suicidal ideation, behavior or attempts or other psychiatric disorder (within 2 years of Screening).
- Any suicidal ideation as identified by endorsement of (answered yes to) any of the items numbered 1-5 on the Columbia Suicide Severity Rating Scale (C-SSRS), if applicable.
- History of alcoholism or drug/chemical abuse within 1 year prior to D-1.
- Alcohol consumption of > 21 units per week for males and > 14 units per week for females, on average. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) during the Screening period.
- Daily use of more than 10 cigarettes/day (on average), or 2 cigars/day (on average), or equivalent use of any tobacco product within 6 weeks prior to Screening.
- Females of pregnant or lactating, or those with a positive pregnancy test at Screening.
- Intolerance to venipuncture for blood sampling or history of fainting at blood drawing or sight of blood, unless deemed acceptable by the Investigator (or designee).
- History of severe Types I-IV hypersensitivity reactions, anaphylaxis, cytokine release syndrome, atopic individuals, or allergic reactions to multiple drugs. If the Investigator is considering enrolling a participant with drug allergies, agreement with the Medical Monitor should be sought.
- History of or suspected allergy or hypersensitivity to the investigational product or its components
- Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to D-1, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to D-1, unless deemed acceptable by the Investigator (or designee).
- Participants with a history of infectious diseases (which may affect the ability of the participant to participate in the study at the discretion of the Investigator), severe trauma, or major surgical operation within 4 weeks prior to Screening.
- Have been vaccinated within 4 weeks prior to Screening or plan to have vaccination during the study.
- Donation of blood or massive blood loss (> 450 mL) OR receipt of blood products within 12 weeks prior to Screening.
- Participation in a clinical study involving administration of an investigational agent/device or vaccine (new chemical entity) or having received a biological product within 12 weeks prior to Screening.
- Poor peripheral venous access.
- Are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- The presence of clinically significant physical examination, vital sign, drug, or ECG findings at Screening or baseline or laboratory findings at Screening that, in the opinion of the Investigator or Medical Monitor, may interfere with any aspect of study conduct or interpretation of results.
- Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.
- Are deemed unsuitable by the Investigator (or designee) for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Veritus Research
Melbourne, Victoria, 3153
Stephen Hall, +61 0494 096 6, stephenhall@veritusresearch.com
Stephen Hall
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Injection in Healthy Subjects
This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.
Read the detailed description
A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD).
The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.
- Conditions
- Overweight or Obese
- Being tested
- Placebo, Subcutaneous single and mutiple dose
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Sub cutaneous injection on the abdomen by a qualified member of study staff.
Subcutaneous single and mutiple doseDrug
Sub cutaneous injection on the abdomen by a qualified member of study staff.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo; Drug: Subcutaneous single and mutiple dose |
| MWN109 injection | Active comparator | * Participants in SAD cohorts will be randomized to receive MWN109 injection or placebo across 5 cohorts. Planned dosage per cohorts are A1:0.25mg, A2:0.75mg, A3:1.5mg, A4:3.0mg, A5:6.0mg.
* Participants in MAD cohorts will be randomized to receive MWN109 injection or placebo across 4 cohorts. The IP will be administered via SC injection once weekly (QW) for approximately 4 doses. Planned dosage per cohorts are: B1-1.5 mg/1.5 mg/1.5 mg/1.5 mg; B2-1.5 mg/3.0 mg/3.0 mg/3.0 mg; B3-1.5 mg/3.0 mg/4.5 mg/6.0 mg; B4-1.5 mg/3.0 mg/6.0 mg/9.0 mg. Receives: Drug: Placebo; Drug: Subcutaneous single and mutiple dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration
Measured: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Number of participants with change in laboratory parameters following treatment administration
Changes in clinical laboratory parameters include urine drug screening, alcohol breath test. serum virology, pregnancy test. hematology, blood chemistry, urinalysis, coagulation function, and thyroid function.
Measured: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Number of participants with change in Vital signs following treatment administration
Vital signs include measurement of heart rate (HR) respiration rate (RR), systolic and diastolic blood pressure (BP) and body temperature.
Measured: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Incidence of anti-drug antibody (ADA) formation following treatment administration
Measured: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Secondary outcomes (9)
PK parameters- Cmax: maximum observed concentration
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- -Tmax: time to reach maximum concentration
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- t½: half-life
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- AUC0-inf: area under the concentration-time curve from time zero to the theoretical infinite time
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- AUCo-t: area under the concentration-time curve from time zero to the time of the last quantifiable concentration
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- AUC0-168h: area under the concentration-time curve from time zero to 168 h post dose
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- CL/F: apparent clearance
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- Vd/F: apparent volume of distribution
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- MRT: mean residence time
Measured: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start17 Mar 2025
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObeseStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guitao Zhang, Study chair, Shanghai Minwei Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859853
- Sponsor's protocol ID
- MWN109-101
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06859853
- Acronym / sponsor ID
- MWN109-101
- Conditions
- Overweight or Obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Nov 2025 (estimated)
- First posted
- 5 Mar 2025 (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 Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.
Detailed description
A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD).
The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo, Drug: Subcutaneous single and mutiple dosePlacebo |
| MWN109 injection | Active comparator | Drug: Placebo, Drug: Subcutaneous single and mutiple dose* Participants in SAD cohorts will be randomized to receive MWN109 injection or placebo across 5 cohorts. Planned dosage per cohorts are A1:0.25mg, A2:0.75mg, A3:1.5mg, A4:3.0mg, A5:6.0mg. * Participants in MAD cohorts will be randomized to receive MWN109 injection or placebo across 4 cohorts. The IP will be administered via SC injection once weekly (QW) for approximately 4 doses. Planned dosage per cohorts are: B1-1.5 mg/1.5 mg/1.5 mg/1.5 mg; B2-1.5 mg/3.0 mg/3.0 mg/3.0 mg; B3-1.5 mg/3.0 mg/4.5 mg/6.0 mg; B4-1.5 mg/3.0 mg/6.0 mg/9.0 mg. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.
- [Part A: SAD] BMI of 19.0 to 40.0 kg/m2 (inclusive). [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kg for males.
- History of stable body weight for 3 months (defined as change < 5%).
- Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
- Females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
Key exclusion criteria (43 listed)
- Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric, disorders as determined by the investigator (or designee).
- History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
- History of insulinoma or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months prior to Screening.
- History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
- Any of the following:
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 |
|---|---|---|
| PlaceboSub cutaneous injection on the abdomen by a qualified member of study staff. | Drug | MWN109 injection, placebo |
| Subcutaneous single and mutiple doseSub cutaneous injection on the abdomen by a qualified member of study staff. | Drug | MWN109 injection, placebo |
Primary outcome
Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration
Time frame: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Number of participants with change in laboratory parameters following treatment administration
Time frame: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Changes in clinical laboratory parameters include urine drug screening, alcohol breath test. serum virology, pregnancy test. hematology, blood chemistry, urinalysis, coagulation function, and thyroid function.
Number of participants with change in Vital signs following treatment administration
Time frame: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Vital signs include measurement of heart rate (HR) respiration rate (RR), systolic and diastolic blood pressure (BP) and body temperature.
Incidence of anti-drug antibody (ADA) formation following treatment administration
Time frame: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
9 secondary outcomes
PK parameters- Cmax: maximum observed concentration
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- -Tmax: time to reach maximum concentration
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- t½: half-life
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- AUC0-inf: area under the concentration-time curve from time zero to the theoretical infinite time
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- AUCo-t: area under the concentration-time curve from time zero to the time of the last quantifiable concentration
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- AUC0-168h: area under the concentration-time curve from time zero to 168 h post dose
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- CL/F: apparent clearance
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- Vd/F: apparent volume of distribution
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
PK parameters- MRT: mean residence time
Time frame: SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- 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.
Guitao Zhang study chair
Shanghai Minwei Biotechnology
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 Subcutaneous single and mutiple dose in people with Overweight or Obese, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in Australia.
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 7 inclusion and 43 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guitao Zhang (+86 13580782564, gt.zhang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration (time frame: Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration). The study lists 4 primary outcomes in all. 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 15 Apr 2025.