Overweight or ObesityPhase 1NCT07057674
A Study of HS-20094 in Overweight or Obese Participants
A Phase 1 study testing HS-20094 AI pen; and HS-20094 MDV pen in people with Overweight or Obesity, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- HS-20094 AI pen; and HS-20094 MDV pen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 29 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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 - 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).
Who cannot join
- 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);
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- 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:
- ① Use of any GLP-1R-related single/multi-target drug that promotes weight loss, including, but not limited to, GLP-1R agonists, glucagon-like peptide-1 receptor/glucagon receptor (GLP-1R/GCGR) agonists, glucagon-like peptide-1 receptor/glucose-dependent insulinotropic polypeptide receptor (GLP-1R/GIPR) agonists, GLP-1R/GIPR/GCGR agonists, etc.;
- ② Any drug that may cause weight gain, including: systemic glucocorticoid medications (except for short-term use of <14 days or topical administration, inhalation, intraocular, or nasal administration), tricyclic antidepressants, atypical antipsychotics, and mood stabilizers (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproate, valproate derivatives, lithium salts), etc.;
- ③ Any Chinese herbal medicines, health care products, meal replacements, weight-reducing teas, etc. or similar products for the purpose of weight loss;
- ④ Any approved or unapproved weight-reducing drugs, such as sibutramine hydrochloride, orlistat, phentermine, phenylpropanolamine, mazindol, phentermine, diethylpropion, lorcaserin, phentermine/topiramate coformulation, naltrexone/bupropion coformulation, etc.;
- ⑤ Any glucose-lowering drugs, such as metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, thiazolidinediones (TZDs), etc.;
- 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 surgery prior to screening that affected gastrointestinal motility;
- 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 after study completion.
- 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 clinical study is less than 7 half-lives (whichever is longer);
- Participants with any of the following conditions:
- 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 and assessed as unsuitable for enrollment.
- Participants with heart rate (HR) of <50 beats per minute or >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 males and >470 ms in females, or any other arrhythmia deemed clinically significant by the investigator. Participants with abnormal QTcF on the first examination should repeat the ECG twice more, and the mean of the three results should be used as the basis for judgment;
- 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 content of 40%, or 150 mL of wine, corresponding to 10 bottles of beer, 500 g of Baijiu, or 3 bottles of red wine per week);
- 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 not interfere with the study);
- 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 venipuncture/indwelling needle;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yu Cao, 18661809090, caoyu1767@126.com
About this study
Official title: A Bioequivalence Study of HS-20094 Multi-dose Pre-filled Injection and HS-20094 Single-dose Pre-filled Injection in Overweight or Obese Participants
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
- Overweight or Obesity
- Being tested
- HS-20094 AI pen;, HS-20094 MDV pen
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20094 AI pen;Drug
Arm 1: Administered SC The dose is escalated every 4 weeks until the target dose of 15 mg is reached. The dose escalation scheme is as follows: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg.
HS-20094 MDV penDrug
The dose is escalated every 4 weeks until the target dose of 15 mg is reached. The dose escalation scheme is as follows: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg.
| Study group | Role | What they receive |
|---|---|---|
| T1 group | Experimental | HS-20094 AI pen administered subcutaneously (SC) once a week. Receives: Drug: HS-20094 AI pen; |
| T2 group | Experimental | HS-20094 MDV pen administered subcutaneously (SC) once a week. Receives: Drug: HS-20094 MDV pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg.
PK parameters of HS-20094 following multiple doses at 15 mg administered via HS-20094 MDV pen and AI pen: AUC0-168h.
Measured: From Day 1 to Day 169
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg.
PK parameters of HS-20094 following multiple doses at 15 mg administered via HS-20094 MDV pen and AI pen: Cmax
Measured: From Day 1 to Day 169
Secondary outcomes (9)
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 10 mg
PK parameters following multiple doses at 10 mg administered via the HS-20094 MDV pen and AI pen: AUC0-168h;
Measured: From Day 1 to Day 169
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 10 mg
PK parameters following multiple doses at 10 mg administered via the HS-20094 MDV pen and AI pen: Cmax
Measured: From Day 1 to Day 169
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Adverse events
Measured: From Day 1 to Day 204
Number of participants with Vital signs
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Measured: From Day 1 to Day 204
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Number of participants with Abnormal Laboratory Values
Measured: From Day 1 to Day 204
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
12-lead ECG, including heart rate, P-R interval, RR interval, QRS, and QTcF
Measured: From Day 1 to Day 204
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Physical examination questionnaire includes: general appearance, skin, lymph nodes, head, throat/thyroid, chest, abdomen, musculoskeletal system, nervous system, cardiovascular system, and others.
Measured: From Day 1 to Day 204
To evaluate the immunogenicity of HS-20094 MDV pen and AI pen after treatment.
ADA of HS-20094: ADA positivity rate
Measured: Days 1, 29, 57, 85, 106, 141, and 169
To evaluate the immunogenicity of HS-20094 MDV pen and AI pen after treatment.
ADA of HS-20094: Including ADA titer.
Measured: Days 1, 29, 57, 85, 106, 141, and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start16 Apr 2025
- Primary completion4 Feb 2026 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057674
- Sponsor's protocol ID
- HS-20094-106
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of HS-20094 Multi-dose Pre-filled Injection and HS-20094 Single-dose Pre-filled Injection in Overweight or Obese Participants
- ClinicalTrials.gov ID
- NCT07057674
- Acronym / sponsor ID
- HS-20094-106
- Conditions
- Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 4 Feb 2026 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1 group | Experimental | Drug: HS-20094 AI pen;HS-20094 AI pen administered subcutaneously (SC) once a week. |
| T2 group | Experimental | Drug: HS-20094 MDV penHS-20094 MDV pen administered subcutaneously (SC) once a week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (46 listed)
- 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):
- ⑧ Blood amylase or blood lipase >2×ULN;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20094 AI pen;Arm 1: Administered SC The dose is escalated every 4 weeks until the target dose of 15 mg is reached. The dose escalation scheme is as follows: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg. | Drug | T1 group |
| HS-20094 MDV penThe dose is escalated every 4 weeks until the target dose of 15 mg is reached. The dose escalation scheme is as follows: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg. | Drug | T2 group |
Primary outcome
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg.
Time frame: From Day 1 to Day 169
PK parameters of HS-20094 following multiple doses at 15 mg administered via HS-20094 MDV pen and AI pen: AUC0-168h.
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg.
Time frame: From Day 1 to Day 169
PK parameters of HS-20094 following multiple doses at 15 mg administered via HS-20094 MDV pen and AI pen: Cmax
9 secondary outcomes
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 10 mg
Time frame: From Day 1 to Day 169
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 10 mg
Time frame: From Day 1 to Day 169
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Time frame: From Day 1 to Day 204
Number of participants with Vital signs
Time frame: From Day 1 to Day 204
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Time frame: From Day 1 to Day 204
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Time frame: From Day 1 to Day 204
To evaluate the safety following administration via the HS-20094 MDV pen and AI pen
Time frame: From Day 1 to Day 204
To evaluate the immunogenicity of HS-20094 MDV pen and AI pen after treatment.
Time frame: Days 1, 29, 57, 85, 106, 141, and 169
To evaluate the immunogenicity of HS-20094 MDV pen and AI pen after treatment.
Time frame: Days 1, 29, 57, 85, 106, 141, and 169
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-20094 AI pen; and HS-20094 MDV pen in people with Overweight or Obesity, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the bioequivalence of HS-20094 MDV pen and AI pen following multiple doses at 15 mg. (time frame: From Day 1 to Day 169). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.