Actively Recruiting
A Bioequivalence Study of HS-20094 Multi-dose Pre-filled Injection and HS-20094 Single-dose Pre-filled Injection in Overweight or Obese Participants
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-07-10
144
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the bioequivalence of two forms of HS-20094 injection pens in adults who are overweight or obese. This multicenter, randomized, open-label, parallel clinical study aims to compare the HS-20094 MDV (multi-dose vial) pen and the HS-20094 AI (auto-injector) pen during multiple doses. The study is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. and focuses on participants aged 18 to 65 years with a body mass index (BMI) of 24.0 kg/m2 or higher. Participants will receive either the HS-20094 AI pen or the HS-20094 MDV pen administered subcutaneously once a week. The dose starts at 2.5 mg and is gradually increased every 4 weeks until reaching the target dose of 15 mg. Both groups follow the same dose escalation schedule. The study includes a treatment period lasting up to Day 169, with safety and immunogenicity monitored through Day 204. During the study, participants will undergo multiple evaluations including laboratory tests, vital sign checks, and immunogenicity assessments at scheduled visits (Days 1, 29, 57, 85, 106, 141, and 169). Researchers will measure the bioequivalence of the two pens by examining how the drug acts in the body at the 15 mg and 10 mg doses. Safety monitoring continues through Day 204. The total study duration per participant is approximately 204 days.
CONDITIONS
Brief 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 follow the study procedures and willing to sign informed consent
- Adult male or female aged 18 to 65 years (inclusive)
- Body mass index (BMI) of 24.0 kg/m2 or higher; weight at least 45 kg for females and 50 kg for males
- Controlled diet and exercise alone for at least 12 weeks before screening with weight change within 5%
- Agree to use effective non-drug contraception from consent signing until 8 weeks after last dose, with no plans for conception or sperm/egg donation during this period
You will not qualify if you...
- Abnormal laboratory results including HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L or <2.8 mmol/L, liver enzymes >3 times normal, triglycerides >500 mg/dL, eGFR <60 mL/min, abnormal thyroid or pancreatic enzymes, abnormal coagulation, low hemoglobin, or positive for certain infections
- History or current severe diseases affecting major body systems deemed unsuitable by investigator
- History of pancreatitis, cholecystitis, gallbladder stones requiring treatment, thyroid tumors, or multiple endocrine neoplasia type 2
- Metabolic or endocrine disorders affecting weight, autoimmune disorders with planned immunosuppressive therapy
- Significant gastrointestinal disorders or surgeries affecting drug absorption
- Allergies or hypersensitivity to study drug components or similar drugs
- Recent blood or bone marrow donation or blood disorders
- History of depression, psychiatric disorders, or high depression questionnaire score
- Previous treatment with similar drugs or use of weight-altering drugs within 3 months
- Recent bariatric surgery or unrecovered surgical trauma
- Recent vaccination or participation in other clinical trials
- Clinically significant abnormalities in physical exams, vital signs, ECG, or laboratory tests
- History of drug abuse, excessive caffeine, smoking, or alcohol use
- Planned surgeries affecting study participation
- Pregnancy, breastfeeding, recent unprotected sex (females)
- Needle or blood phobia or inability to tolerate blood draws
- Other investigator-assessed unsuitability or withdrawal from study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks (Day 1 to Day 169)
Participants receive weekly subcutaneous injections of HS-20094 using either the AI pen or MDV pen, with dose escalation every 4 weeks until reaching 15 mg.
Weekly visits for up to 24 weeks
Duration - Up to 5 weeks after treatment (Day 170 to Day 204)
Participants are monitored for safety and immunogenicity after completing treatment.
Several follow-up visits during this period
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
Research Team
Y
Yu Cao
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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