Healthy VolunteersPhase 1NCT07824804
Phase 1 Clinical Study of MWN117 Injection in Healthy Participants and Participants With Obesity
A Phase 1 study testing MWN117 in people with Healthy Volunteers and Obesity, 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, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants. The study consists of two parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Obesity
- What is being tested?
- MWN117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2026to Mar 2028
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 55 years (inclusive) at the time of informed consent signing; male or female.
- Body mass index (BMI): Part A, healthy participants, 20.0-27.9 kg/m² (inclusive); Part B, obese participants, 28.0-35.0 kg/m² (inclusive), with body weight > 60 kg for males and > 50 kg for females.
- Stable weight for 3 months prior to screening (self-reported weight change ≤ 5%), with no major changes in diet or physical activity, and the ability to maintain a stable lifestyle during the study.
- Participants and their sexual partners must have no plans for pregnancy or sperm/oocyte donation from the time of ICF signing until at least 12 months post-dose; participants must use effective non-pharmacological contraception during this period. Female participants of childbearing potential must have a negative serum pregnancy test at screening.
Who cannot join
- Use of GLP-1 receptor agonists (e.g., liraglutide, semaglutide, tirzepatide) within 3 months prior to screening.
- Use of medications significantly affecting body weight within 3 months prior to screening, including but not limited to: orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, weight-affecting herbal products, or meal replacements; cumulative or continuous use of systemic steroids ≥ 14 days (IV/oral), tricyclic antidepressants, psychiatric medications, or sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium).
- Endocrine disorders that may significantly affect body weight (e.g., Cushing's syndrome, hypothyroidism, or hyperthyroidism), or drug-induced, monogenic, or genetic obesity syndromes.
- History of surgery or device treatment for overweight or obesity.
- Diagnosis of type 1 or type 2 diabetes, or laboratory findings suggesting diabetes during screening (HbA1c ≥ 6.5%, fasting serum glucose ≥ 7.0 mmol/L, or random glucose ≥ 11.1 mmol/L).
- Clinically significant laboratory abnormalities at screening: a) ALT, AST, GGT, or TBIL > 1.5 × ULN; b) Serum Cr > 1.2 × ULN or eGFR < 80 mL/min/1.73 m²; c) Fasting TG > 5.65 mmol/L (500 mg/dL).
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- 12-lead ECG abnormalities at screening: a) PR interval ≥ 210 ms; b) QRS duration ≥ 120 ms; c) QTcF > 450 ms (males) or > 470 ms (females); d) Any other clinically significant ECG abnormality as judged by the investigator.
- Use of liver-targeted antisense oligonucleotides (ASO) or small interfering RNA (siRNA) drugs within 12 months prior to screening.
- History of hypersensitivity to any component of MWN117, other siRNA drugs, or GalNAc-conjugated drugs; or allergy to two or more drugs or foods; or history of severe allergic reactions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan
Jianchang He, Master of Pharmacy, +86 13700680697, Hejc@yn-cprc.com
Weibo Wen, Master's degree, +86 13187705850, 850923441@qq.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWN117 Injection in Healthy and Obese Participants
This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants.
The study consists of two parts. Part A includes two dose cohorts enrolling healthy participants, and Part B includes four dose cohorts enrolling obese participants. A total of 48 participants will be enrolled. Within each dose cohort, participants will be randomly assigned to receive a single subcutaneous injection of MWN117 or matching placebo.
The primary endpoint is safety, assessed by adverse events and related examinations. Secondary endpoints include plasma pharmacokinetic (PK) parameters and urine PK parameters.
- Conditions
- Healthy Volunteers, Obesity
- Being tested
- MWN117, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN117Drug
A1, A2; administered subcutaneously (SC)
MWN117Drug
B1, B2, B3, B4; administered SC
PlaceboDrug
administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A consists of 2 dose groups. Healthy participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN117 or placebo. Receives: Drug: MWN117; Drug: Placebo |
| Part B | Experimental | Part B consists of 4 dose groups. Obese participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN117 or placebo. Receives: Drug: MWN117; 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: Up to Day 169
Secondary outcomes (8)
Area Under the Curve From Time 0 to the Last Measurable Time Point (AUC0-last)
AUC0-last of MWN117.
Measured: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN117.
Measured: Up to 48 hours post-dose
Maximum Plasma Concentration (Cmax)
Cmax of MWN117.
Measured: Up to 48 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of MWN117.
Measured: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of MWN117.
Measured: Up to 48 hours post-dose
Renal Clearance (CLr)
CLr of MWN117.
Measured: Up to 48 hours post-dose
Cumulative Excretion Amount (Ae)
Ae of MWN117.
Measured: Up to 48 hours post-dose
Cumulative Excretion Fraction (Fe)
Fe of MWN117.
Measured: Up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start18 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 48 participants (estimated)
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
- NCT07824804
- Sponsor's protocol ID
- MWN117-101
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 17 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWN117 Injection in Healthy and Obese Participants
- ClinicalTrials.gov ID
- NCT07824804
- Acronym / sponsor ID
- MWN117-101
- Conditions
- Healthy Volunteers, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 17 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, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants.
The study consists of two parts. Part A includes two dose cohorts enrolling healthy participants, and Part B includes four dose cohorts enrolling obese participants. A total of 48 participants will be enrolled. Within each dose cohort, participants will be randomly assigned to receive a single subcutaneous injection of MWN117 or matching placebo.
The primary endpoint is safety, assessed by adverse events and related examinations. Secondary endpoints include plasma pharmacokinetic (PK) parameters and urine PK parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: MWN117, Drug: PlaceboPart A consists of 2 dose groups. Healthy participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN117 or placebo. |
| Part B | Experimental | Drug: MWN117, Drug: PlaceboPart B consists of 4 dose groups. Obese participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN117 or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 55 years (inclusive) at the time of informed consent signing; male or female.
- Body mass index (BMI): Part A, healthy participants, 20.0-27.9 kg/m² (inclusive); Part B, obese participants, 28.0-35.0 kg/m² (inclusive), with body weight > 60 kg for males and > 50 kg for females.
- Stable weight for 3 months prior to screening (self-reported weight change ≤ 5%), with no major changes in diet or physical activity, and the ability to maintain a stable lifestyle during the study.
- Participants and their sexual partners must have no plans for pregnancy or sperm/oocyte donation from the time of ICF signing until at least 12 months post-dose; participants must use effective non-pharmacological contraception during this period. Female participants of childbearing potential must have a negative serum pregnancy test at screening.
Key exclusion criteria (9 listed)
- Use of GLP-1 receptor agonists (e.g., liraglutide, semaglutide, tirzepatide) within 3 months prior to screening.
- Use of medications significantly affecting body weight within 3 months prior to screening, including but not limited to: orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, weight-affecting herbal products, or meal replacements; cumulative or continuous use of systemic steroids ≥ 14 days (IV/oral), tricyclic antidepressants, psychiatric medications, or sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium).
- Endocrine disorders that may significantly affect body weight (e.g., Cushing's syndrome, hypothyroidism, or hyperthyroidism), or drug-induced, monogenic, or genetic obesity syndromes.
- History of surgery or device treatment for overweight or obesity.
- Diagnosis of type 1 or type 2 diabetes, or laboratory findings suggesting diabetes during screening (HbA1c ≥ 6.5%, fasting serum glucose ≥ 7.0 mmol/L, or random glucose ≥ 11.1 mmol/L).
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 |
|---|---|---|
| MWN117A1, A2; administered subcutaneously (SC) | Drug | Part A |
| MWN117B1, B2, B3, B4; administered SC | Drug | Part B |
| Placeboadministered SC | Drug | Part A, Part B |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to Day 169
The incidence of adverse Events (AEs) and serious adverse events (SAEs).
8 secondary outcomes
Area Under the Curve From Time 0 to the Last Measurable Time Point (AUC0-last)
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: Up to 48 hours post-dose
Maximum Plasma Concentration (Cmax)
Time frame: Up to 48 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
Time frame: Up to 48 hours post-dose
Renal Clearance (CLr)
Time frame: Up to 48 hours post-dose
Cumulative Excretion Amount (Ae)
Time frame: Up to 48 hours post-dose
Cumulative Excretion Fraction (Fe)
Time frame: Up to 48 hours post-dose
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 17 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.
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 MWN117 in people with Healthy Volunteers and Obesity, 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 9 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: opening soon, as of the sponsor's last update on 17 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?
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 Wanxiang Chen (+86 13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to Day 169). 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 17 Sep 2026.