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New treatment option for Overweight or Obesity
Official title A Study of HS-20094 in Overweight or Obese Participants
ClinicalTrials.gov ID: NCT07057674
What this study is testing
What is HS-20094 AI pen;?
HS-20094 AI pen; is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight or obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- 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...
You likely can't join 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...
- 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);
See the full eligibility criteria
Who can join
- 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 -...
- 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...
What rules you out
- 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...
- 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 \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)...
- Any use of drugs or treatments that may cause significant weight gain or loss within 3 months prior to screening: ① Use of any GLP-1R-related single/multi-target drug that promotes weight loss, including, but not...
- History of bariatric/metabolic surgery within 12 months prior to screening, or participants who have not recovered from any surgery or trauma at screening, or participants who have recovered from gastrointestinal...
- Participants who have received immunization of any vaccine within four weeks prior to the first dose of the investigational product, or who plan to receive immunization of any vaccine during the study or within 2 weeks...
- Participants who have participated in any other clinical studies and received administration of investigational products within 3 months prior to screening; or the time interval from administration in the previous...
- Participants with abnormal findings in physical examination, vital signs, clinical laboratory tests, abdominal ultrasound, thyroid color Doppler ultrasound, etc., deemed by the investigator to be clinically significant...
- Participants with heart rate (HR) of \ 100 beats per minute by 12-lead electrocardiogram (ECG) during screening. A retest is allowed, and the participant will be excluded if both tests fail;
- Presence of any of the following abnormalities on 12-lead ECG at screening: second or third degree AV block, long QT syndrome, pre-excitation syndrome, ventricular tachycardia, atrial fibrillation, or QTcF \>450 ms in...
- History of drug abuse, drug dependence, or illicit drug use within 5 years prior to screening, or positive urine drug screening;
- Participants who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups per day on average, 1 cup = 200 mL) within 3 months prior to screening;
- Participants who smoke an average of more than 5 cigarettes per day within the 3 months prior to screening;
- Participants who frequently consume alcohol within 3 months prior to screening (i.e., weekly alcohol intake exceeding 14 units, where 1 unit = 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of spirits with alcohol...
- Planned bariatric surgery, acupuncture for weight loss, liposuction, or abdominoplasty during the study; or other planned surgery during the study (except for minor surgery that, in the opinion of the investigator, does...
- Female participants who are in the lactation period within 1 month prior to screening or during the study; or female participants with positive result in pregnancy test;
- Participants who have engaged in unprotected sexual intercourse within 14 days prior to study treatment (applicable to female participants only);
- Participants with history of needle phobia or blood phobia, or participants assessed by the investigator as having difficulty in blood collection, or participants cannot tolerate blood collection via...
- Other participants deemed unsuitable for participating in the study by the investigator or participants who voluntarily withdraw from the study or who are lost to follow-up for personal reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Qingdao, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Qingdao, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.