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

NCT07824804 | Not Yet Recruiting Phase 1

• 1 other identifier: MWN117-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

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

  Up to Day 169

Secondary Outcomes (8)

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

  Up to 48 hours post-dose

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

  Up to 48 hours post-dose

• Maximum Plasma Concentration (Cmax)

  Up to 48 hours post-dose

• Time to Reach Maximum Plasma Concentration (Tmax)

  Up to 48 hours post-dose

• Elimination Half-Life (t1/2)

  Up to 48 hours post-dose

Study Arms (2)

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.

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.

Drug: MWN117; Drug: Placebo

Interventions

MWN117 DRUG

A1, A2; administered subcutaneously (SC)

Part A

Placebo DRUG

administered SC

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wanxiang Chen

CONTACT

+86 13359015677; chenwanxiang@minweibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)