Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight , Obesity

Outcome Measures

Primary Outcomes (6)

The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) to the investigational product
Incidence of treatment-emergent adverse events (TEAEs)
From Day 1 to Day 169
Number of participants with abnormal vital signs
From Day 1 to Day 169
Number of participants with abnormal ECG readings
From Day 1 to Day 169
Number of participants with abnormal physical examination findings
From Day 1 to Day 169
Number of participants with abnormal clinical laboratory measurements
From Day 1 to Day 169
Number of participants with abnormal ophthalmological examination findings
From Day 1 to Day 169

Secondary Outcomes (14)

Maximum Concentration (Cmax)
From Day 1 to Day 57
Time to Reach Maximum Concentration (Tmax)
From Day 1 to Day 57
Under the Concentration Versus Time Curve (AUC)
From Day 1 to Day 57
Apparent Terminal Elimination Half-life (t1/2)
From Day 1 to Day 57
Steady State Maximum Concentration (Cmax,ss)
From Day 1 to Day 169
+9 more secondary outcomes

Study Arms (3)

MWN110 S

EXPERIMENTAL

MWN110 Cohort S consists of 8 dose groups, with doses ranging from 15 mg to 1200 mg. Healthy participants in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN110 or placebo.

Drug: MWN110Drug: Placebo

MWN110 MA

EXPERIMENTAL

MWN110 Cohort MA consists of 2 dose groups, with specific doses to be determined based on results from MWN110 Cohort S. In all dose groups, overweight or obese participants are randomized to receive 5 subcutaneous doses of MWN110 or placebo, administered once weekly.

Drug: MWN110Drug: Placebo

MWN110 MB

EXPERIMENTAL

Interventions

MWN110Drug

S1, S2, S3, S4, S5, S6, S7, S8; administered subcutaneously (SC)

MWN110 S

MWN110Drug

M1, M2; administered SC

MWN110 MA

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1/3.
Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 20.0 to 40.0 kg/m\^2 (inclusive).

Sponsors & Collaborators

Shanghai Minwei Biotechnology Co., Ltd
Industrylead

Study Sites (1)

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

Kunming, Yunnan, China

Jianchang He, Master of PharmacyCONTACT13700680697 hejc@yn-cprc.com

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wanxiang Chen

CONTACT

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

August 14, 2026

First Posted

August 21, 2026

Study Start

August 26, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 2027

You may not qualify if:

Known or suspected allergy to the investigational product or its excipients, or history of severe allergy (including any food or drug allergy).
Body weight change \>5% within 3 months prior to screening (weight change % = \[maximum weight in 3 months - minimum weight in 3 months\] / maximum weight in 3 months x 100%).
Diagnosed with secondary overweight or obesity.
History of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis); serum amylase or lipase above the upper limit of normal.
Known history of disease or comorbidity affecting skeletal muscle protein.
At screening, the presence of active acne, pyogenic dermatosis, allergic dermatosis, inflammatory dermatosis, infectious dermatosis, unhealed skin wounds, extensive skin lesions, or skin abnormalities such as vegetations or masses, judged by the investigator as unsuitable for participation.
History of infectious disease within 4 weeks prior to screening (judged by the investigator as potentially significantly affecting safety evaluation), history of severe trauma, or history of major surgery within 3 months, or planned surgery during the study period.
At screening, any laboratory test meeting any of the following criteria: a) fasting blood glucose \>6.1 mmol/L or \<3.9 mmol/L; b) alanine aminotransferase, aspartate aminotransferase, or total bilirubin \>1.5 × upper limit of normal (ULN); c) estimated glomerular filtration rate \<70 mL/min/1.73 m² (CKD-EPI equation) or urinary protein positive (1+ or above); d) fasting triglycerides ≥3.42 mmol/L (Part 1) or \>5.64 mmol/L (Part 2); e) hemoglobin \<100 g/L (females) or \<110 g/L (males); f) blood uric acid (UA) \>540 μmol/L.
At screening, 12-lead electrocardiogram showing heart rate \<50 bpm or \>100 bpm, second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF \>460 ms (female) or \>450 ms (male), or other electrocardiogram abnormalities judged by the investigator as requiring pharmacological intervention.
Participants who have undergone dieting or weight-loss treatment within 30 days prior to the first dose, or who have experienced major changes in lifestyle habits.
Use of GLP-1 receptor agonists, weight-loss drugs, systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months before the first dose.
Engaged in strenuous muscle exercise, high-intensity resistance training, or regular muscle-strengthening activities within 30 days before the first dose.

Phase 1 Clinical Study of MWN110 Injection in Healthy Participants and Overweight or Obese Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (14)

Study Arms (3)

MWN110 S

MWN110 MA

MWN110 MB

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (14)

Study Arms (3)

MWN110 S

MWN110 MA

MWN110 MB

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations