A Study of HS-20094 in Overweight or Obese Participants

Recruiting now · Phase 1

Conditions studied: Overweight or Obesity

In brief

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.

Key facts

Study ID

NCT07057674

Run by

Jiangsu Hansoh Pharmaceutical Co., Ltd.

People needed

144

Starts

2025-04-16

Expected to finish

2026-05-29

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand the procedures and methods of this study, willing to strictly adhere to the clinical study protocol to complete this study, and voluntarily sign the informed consent form;
• Adult male or female participants (aged 18-65 years (inclusive), calculated based on the date of signing the informed consent form);
• Body mass index (BMI) ≥24.0 kg/m2 (BMI = weight (kg) / height2 (m2)); body weigh ≥45 kg for female participants and ≥50 kg for male participants.
• Self-reported diet/exercise control alone for at least 12 weeks prior to screening, with a weight change of ≤5% in the past 12 weeks (based on self-report); calculation formula for weight change: (highest weight - lowest weight within 12 weeks prior to screening) ∕ highest weight * 100%;
• Agree to take effective contraceptive measures from the signing of the informed consent form until 8 weeks after the last dose, and have no plans for conception or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the study).

You may not qualify if…

• Participants with any of the following examination abnormalities at screening:
• Laboratory test results meet any of the following criteria (if there is a clear reason for retesting, one re-examination can be conducted within the time window of the screening period, and the results of this re-examination will be used as the basis for screening):
• HemoglobinA1c (HbA1c) ≥6.5% or fasting plasma glucose ≥7.0 mmol/L;
• Fasting plasma glucose <2.8 mmol/L;
• Alanine aminotransferase > 3 × ULN, or aspartate aminotransferase > 3 × ULN, or total bilirubin > 1.5 × ULN;
• Triglyceride >500 mg/dL (5.64 mmol/L);
• Estimated glomerular filtration rate (absolute eGFR) based on the CKD-EPI equation <60 mL/min;
• Serum calcitonin level ≥50 ng/L; ⑦ Thyroid-stimulating hormone >6.0 mIU/L or <0.4 mIU/L;
• ⑧ Blood amylase or blood lipase >2×ULN;
• Prothrombin time (PT)-international normalized ratio (INR) exceeds the upper limit of normal, and the investigator determines the abnormality to be clinically significant, making it unsuitable for the participant to be enrolled; ⑩ Hemoglobin <110 g/L (male) or <100 g/L (female); ⑪ Positive test result for any one or more of the following items: hepatitis B surface antigen, hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody;
• Presence of any of the following diseases or medical history prior to screening or randomization:
• Participants who currently have or with history of severe diseases involving nervous system, psychiatric system, digestive system, circulatory system, respiratory system, urinary system, etc., or have newly developed diseases before administration of the investigational product, and therefore are deemed by the investigator as unsuitable for participation in this study;
• Past history or ultrasound findings during screening period include any of the following conditions: medical history of chronic pancreatitis, acute pancreatitis, cholecystitis, or symptomatic/treatment-requiring gallbladder stones (except for participants who have undergone cholecystectomy but are deemed eligible for enrollment by the investigator);
• Participants with a history or family history of thyroid C-cell tumors or multiple endocrine neoplasia type 2;
• Participants with a history of metabolic disorders (such as unexplained recurrent hypoglycemia) who are deemed unsuitable for participation in this study upon the evaluation by the investigator;
• Presence of endocrine diseases or medical history that may significantly affect weight (e.g., Cushing's syndrome, hypothyroidism, hyperthyroidism, etc., except for hypothyroidism if thyroid hormone replacement dosage has been stabilized for at least 6 months), or obesity due to a single gene mutation or hereditary obesity syndrome, etc.;
• Presence of autoimmune disorders and planned use of systemic glucocorticoid therapy or immunosuppressive therapy during the study;
• Participants with a history of significant gastric emptying abnormalities, severe gastrointestinal disorder, or gastrointestinal surgery (excluding polypectomy, appendicectomy, and haemorrhoid operation) who are deemed unsuitable for participation in this study upon the evaluation by the investigator;
• Participants who have undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion, and are deemed unsuitable for enrollment by the investigator;
• Participants who are prone to allergic reactions or with allergic constitution (e.g., those allergic to pollen, two or more drugs/foods), or participants with known hypersensitivity to any component of the investigational product or similar drugs (Tirzepatide, GLP-1R agonists, or compounds containing GLP-1R agonists); or participants with a history of photosensitivity.
• Blood donation and/or blood loss ≥400 mL or bone marrow donation within 3 months prior to screening; or haemoglobinopathy, haemolytic anaemia, or sickle cell anaemia at screening;
• Past medical history of moderate to severe depression; or history of suicidal ideation or suicidal behavior; or past medical history of serious psychiatric disorders, e.g., schizophrenia, bipolar affective disorder, etc.; or a score of ≥9 on the Patient Health Questionnaire-9 (PHQ-9) at screening (self-rated by the participant);
• Participants who received any of the following drugs or treatments prior to screening:
• Participants who have been previously treated with similar drugs of HS-20094 (Tirzepatide, GLP-1 analogues, or related compounds), and/or those who require the use of DPP-4 inhibitors (drugs affecting GLP-1 levels) during the study;
• Any use of drugs or treatments that may cause significant weight gain or loss within 3 months prior to screening:

Where it is running

• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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