Actively Recruiting
A Study of HS-20094 in Overweight or Obese Participants
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-07-10
144
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, open-label, parallel clinical study to evaluate the bioequivalence of the HS-20094 MDV pen and AI pen in overweight or obese subjects.
CONDITIONS
Official Title
A Study of HS-20094 in Overweight or Obese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and agree to follow study procedures and provide informed consent
- Adult male or female aged 18 to 65 years inclusive
- Body mass index (BMI) of 24.0 kg/m2 or greater
- Female participants weighing at least 45 kg; male participants weighing at least 50 kg
- Stable weight with diet and exercise control alone for at least 12 weeks prior to screening, with less than or equal to 5% weight change
- Willing to use effective non-drug contraception from signing consent until 8 weeks after last dose, with no plans for conception or sperm/egg donation during this time
You will not qualify if you...
- Lab abnormalities including HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L or <2.8 mmol/L, elevated liver enzymes, triglycerides >500 mg/dL, low kidney function (eGFR <60 mL/min), abnormal thyroid or amylase/lipase levels, abnormal coagulation, low hemoglobin, or positive tests for hepatitis B/C, HIV, or syphilis
- History or current severe diseases of nervous, psychiatric, digestive, circulatory, respiratory, or urinary systems deemed unsuitable by investigator
- History of pancreatitis, cholecystitis, symptomatic gallstones, or thyroid C-cell tumors or multiple endocrine neoplasia type 2
- Metabolic or endocrine disorders significantly affecting weight, or autoimmune disorders requiring systemic glucocorticoids or immunosuppressants
- Significant gastrointestinal disorders or surgeries affecting drug absorption
- Allergies to study drug components or related drugs, or history of photosensitivity
- Recent blood or bone marrow donation, hemoglobin disorders, or anemia
- History of moderate to severe depression, suicidal behavior, serious psychiatric disorders, or high PHQ-9 score
- Prior treatment with HS-20094-related drugs or need for DPP-4 inhibitors during study
- Use of medications causing significant weight change within 3 months prior to screening
- Recent bariatric surgery or unrecovered surgery/trauma
- Recent vaccination or participation in other clinical trials with investigational products
- Clinically significant abnormal findings in physical exam, vital signs, labs, or imaging
- Abnormal heart rate or ECG findings
- History of drug abuse or positive drug screening
- Excessive caffeine, alcohol consumption, or smoking
- Planned weight loss surgeries or procedures during study
- Female participants currently breastfeeding or pregnant
- Recent unprotected sexual intercourse (for females)
- Needle or blood phobia or difficulty tolerating blood collection
- Other conditions deemed unsuitable by investigator or voluntary withdrawal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Y
Yu Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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