ClinicalTrials.gg
Not yet recruitingNCT07824804Updated Sep 17, 2026

Phase 1 Clinical Study of MWN117 Injection in Healthy Participants and Participants With Obesity

A Phase 1 interventional study of MWN117 and MWN117 in Healthy Volunteers and Obesity, sponsored by Shanghai Minwei Biotechnology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

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

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 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.

Planned enrollment
12th of 14
48 · median 88
Started
2026
with 6 others
Phase 1
8 of 14
5 open now
Registered
14th of 14
by date

Among the 14 studies in Obesity by Shanghai Minwei Biotechnology Co., Ltd, this one is the 12th largest by planned enrollment, is one of 7 that started in 2026, is one of 8 in phase 1, and was the 14th 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. 7 started in 2026.

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, 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.

03

Conditions studied

  • Healthy Volunteers
  • Obesity

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 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. Aged 18 to 55 years (inclusive) at the time of signing; male or female.
  2. (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.
  3. 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.
  4. 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 during this period. Female participants of must have a negative serum pregnancy test at screening.

Exclusion criteria

Exclusion Criteria:

  1. Use of GLP-1 receptor agonists (e.g., liraglutide, semaglutide, tirzepatide) within 3 months prior to screening.
  2. 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 ≥ 14 days (IV/oral), tricyclic antidepressants, psychiatric medications, or sedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium).
  3. Endocrine disorders that may significantly affect body weight (e.g., Cushing's syndrome, hypothyroidism, or hyperthyroidism), or drug-induced, monogenic, or genetic obesity syndromes.
  4. History of surgery or device treatment for overweight or obesity.
  5. Diagnosis of type 1 or type 2 diabetes, or laboratory findings suggesting diabetes during screening ( ≥ 6.5%, fasting serum glucose ≥ 7.0 mmol/L, or random glucose ≥ 11.1 mmol/L).
  6. laboratory abnormalities at screening: a) , AST, GGT, or > 1.5 × ; b) Serum Cr > 1.2 × ULN or \< 80 mL/min/1.73 m²; c) Fasting TG > 5.65 mmol/L (500 mg/dL).
  7. 12-lead abnormalities at screening: a) PR interval ≥ 210 ms; b) QRS duration ≥ 120 ms; c) > 450 ms (males) or > 470 ms (females); d) Any other clinically significant ECG abnormality as judged by the investigator.
  8. Use of liver-targeted antisense oligonucleotides (ASO) or small interfering RNA (siRNA) drugs within 12 months prior to screening.
  9. History of 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.
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.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

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.

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.

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.

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.

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.

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.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

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.

05

Study design

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

Study arms

  • Experimental
    Part A

    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.

    Drug: MWN117 · Drug: Placebo

  • Experimental
    Part B

    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.

    Drug: MWN117 · Drug: Placebo

Interventions

  • DrugMWN117

    A1, A2; administered subcutaneously (SC)

  • DrugMWN117

    B1, B2, B3, B4; administered SC

  • DrugPlacebo

    administered SC

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events (AEs)

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

    Time frame: Up to Day 169

Secondary outcomes

  1. Area Under the Curve From Time 0 to the Last Measurable Time Point (AUC0-last)

    AUC0-last of MWN117.

    Time frame: Up to 48 hours post-dose

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

    AUC0-inf of MWN117.

    Time frame: Up to 48 hours post-dose

  3. Maximum Plasma Concentration (Cmax)

    Cmax of MWN117.

    Time frame: Up to 48 hours post-dose

  4. Time to Reach Maximum Plasma Concentration (Tmax)

    Tmax of MWN117.

    Time frame: Up to 48 hours post-dose

  5. Elimination Half-Life (t1/2)

    t1/2 of MWN117.

    Time frame: Up to 48 hours post-dose

  6. Renal Clearance (CLr)

    CLr of MWN117.

    Time frame: Up to 48 hours post-dose

  7. Cumulative Excretion Amount (Ae)

    Ae of MWN117.

    Time frame: Up to 48 hours post-dose

  8. Cumulative Excretion Fraction (Fe)

    Fe of MWN117.

    Time frame: Up to 48 hours post-dose

07

Study locations

1 site
  • The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
    Kunming, Yunnan, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07824804
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Sep 18, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 17, 2026

Study contacts

Wanxiang Chen
Contact
chenwanxiang@minweibiotech.com
+86 13359015677

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion