Non-diabetic ObesityPhase 4NCT06863363
PEG-rhGH and Semaglutide Combination Therapy in Non-Diabetic Obese Adults
A Phase 4 study testing PEG-rhGH Injection + Semaglutide Injection and Semaglutide Injection in people with Non-diabetic Obesity, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of PEG-rhGH Injection combined with Semaglutide Injection versus Semaglutide Injection monotherapy in improving body composition (lean body mass, fat mass, etc.) in non-diabetic obese adults, while also analyzing changes in body weight, blood glucose, and other… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non-diabetic Obesity
- What is being tested?
- PEG-rhGH Injection + Semaglutide Injection and Semaglutide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 years (minimum age) and 50 years (maximum age), inclusive
- Gender: Male or female, with a ratio of male to female being 2:1;
- Body Mass Index (BMI) ≥28 kg/m²;
- No prior use of semaglutide injection or antidiabetic medications;
- Free Thyroxine (FT4) levels within normal range at screening;
- Testosterone levels within normal range at screening (males only);
- No plans for pregnancy from the time of signing the ICF until 2 months after the study ends, willingness to take effective contraceptive measures to prevent pregnancy or causing a partner's pregnancy, and no plans for sperm or egg donation during the study period;
- Participants must voluntarily agree to and be able to comply with all scheduled visits, treatment plans, laboratory tests, special examinations, neurological assessments, and other trial procedures, and sign a written informed consent form.
Who cannot join
- Unable to accept regular follow-up;
- Those who have difficulty with self-injection;
- Weight change >5.0% in the 12 weeks prior to screening (self-reported);
- History of allergic reactions to the study drug or similar drugs;
- Evaluated by the investigator as unable to tolerate subcutaneous injection, such as those undergoing anticoagulant therapy, thrombocytopenia, known bleeding disorders, or idiopathic thrombocytopenic purpura;
- Planning surgery within 1 year; history of gastrointestinal surgery (excluding polypectomy and appendectomy);
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- Positive blood HCG during screening; breastfeeding women; postmenopausal women; women with FSH >30 IU/L during screening;
- Any of the following: myocardial infarction, stroke, unstable angina requiring hospitalization, or transient ischemic attack within 180 days before screening, classified as NYHA class III or higher;
- Clinically significant severe ECG abnormalities (e.g., QT prolongation [>450 ms in men, >470 ms in women], ventricular Flutter, ventricular fibrillation, torsades de pointes, sick sinus syndrome, third-degree heart block without pacemaker therapy, and other severe abnormalities as assessed by the investigator), uncontrolled blood pressure despite treatment/untreated (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg during screening, systolic BP <90 mmHg and/or diastolic BP <50 mmHg), or other cardiovascular diseases deemed unsuitable for the study by the investigator;
- Triglycerides ≥500 mg/dL (5.65 mmol/L);
- Current or past history of malignancy, or currently having nodules with malignant potential such as thyroid nodules with TIRADS grade ≥4;
- Tumor markers during screening: CA125 (for women), CA199, CEA, AFP above upper limit of normal range; PSA above upper limit of normal range (for men);
- Hemoglobin A1c ≥6.5% during screening;
- History of diabetes (type 1, type 2, special types, or gestational diabetes) or currently using injectable or oral antidiabetic medications;
- Current or past history of acromegaly;
- Proliferative or severe non-proliferative diabetic retinopathy at screening; fundus examination within 90 days before randomization: proliferative retinopathy or macular edema requiring acute treatment;
- Used growth hormone therapy in the past 6 months;
- Used any weight loss medications in the past 3 months; previously underwent obesity surgery or planned obesity surgery during the study;
- Any of the following laboratory tests at screening: AST or ALT >2.5 ULN; total bilirubin >1.5 ULN; TSH <0.4 or >6 mIU/L; calcitonin >50 ng/L;
- IGF-1 SDS >2.0 (age and gender matched);
- Serum creatinine >1.5 ULN, eGFR <60 mL/min/1.73 m² [using the modified simplified MDRD equation: eGFR = 175 × (serum creatinine in mg/dL)^-1.234 × age^-0.179 × 0.79 for women], or kidney impairment requiring dialysis;
- History of pancreatitis, or current acute or chronic pancreatitis;
- History of cholecystitis, or current gallbladder/biliary disease symptoms, or treatable gallstones or polyps;
- Family or personal history of multiple endocrine neoplasia type 2 or thyroid cancer (family defined as first-degree relatives);
- Prior history of pituitary mass;
- History of seizures;
- Participated in another clinical trial with approved or investigational drugs/devices within 90 days before screening (excluding those who only signed the consent without receiving any intervention);
- History of substance abuse and/or alcoholism, or mental disorders; during screening, had impaired consciousness including somnolence, stupor, coma, confusion;
- Questionnaire PHQ-9 score ≥15; history of suicidal behavior; Columbia-Suicide Severity Rating Scale (C-SSRS) question 1 or 2 indicating suicidal ideation (answering "yes" to question 1 or 2);
- Other reasons for exclusion as deemed by the investigator, such as any situation endangering participant safety or affecting compliance with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lin ZHAO contact
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaoying Li, +86 136 5191 3857, xiaoying_li@hotmail.com
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel-controlled Clinical Trial Comparing the Efficacy and Safety of PEG-rhGH Injection Combined with Semaglutide Injection Versus Semaglutide Injection Monotherapy in Body Composition of Non-Diabetic Obese Adults
This study aims to evaluate the efficacy and safety of PEG-rhGH Injection combined with Semaglutide Injection versus Semaglutide Injection monotherapy in improving body composition (lean body mass, fat mass, etc.) in non-diabetic obese adults, while also analyzing changes in body weight, blood glucose, and other metabolic parameters.
- Conditions
- Non-diabetic Obesity
- Being tested
- PEG-rhGH Injection + Semaglutide Injection, Semaglutide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhGH Injection + Semaglutide InjectionDrug
Polyethylene Glycol Recombinant Human Growth Hormone Injection (PEG-rhGH Injection), 54 IU/9.0 mg/1.0 mL/amp.; Subcutaneous injection using pen-injector, once weekly at a dose of 2 mg per week (weeks 1-40).
Semaglutide Injection, 0.68 mg/mL，1.5 mL；1.34 mg/mL，1.5 mL；1.34 mg/mL，3 mL；2.27 mg/mL，3 mL；3.2 mg/mL，3 mL; Subcutaneous injection once weekly using pre-filled pen including dosage escalation period (W1-W16): starting dose 0.25 mg, increasing every 4 weeks (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) and maintenance treatment period (W17-W40): at a dose of 2.4 mg for 24 weeks
Semaglutide InjectionDrug
Semaglutide Injection, 0.68 mg/mL，1.5 mL；1.34 mg/mL，1.5 mL；1.34 mg/mL，3 mL；2.27 mg/mL，3 mL；3.2 mg/mL，3 mL; Subcutaneous injection once weekly using pre-filled pen including dosage escalation period (W1-W16): starting dose 0.25 mg, increasing every 4 weeks (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) and maintenance treatment period (W17-W40): at a dose of 2.4 mg for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhGH Injection + Semaglutide Injection | Experimental | Not described Receives: Drug: PEG-rhGH Injection + Semaglutide Injection |
| Semaglutide Injection | Active comparator | Not described Receives: Drug: Semaglutide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in lean body weight (kg) from baseline
Measured: Week 40
Secondary outcomes (10)
Change in lean body mass percentage (%)
Measured: During 40 weeks
Change in appendicular muscle mass (kg)
Measured: During 40 weeks
Change in trunk muscle mass (kg)
Measured: During 40 weeks
Change in appendicular fat mass (kg)
Measured: During 40 weeks
Change in trunk fat mass (kg)
Measured: During 40 weeks
Percentage change in total fat mass (%)
Measured: During 40 weeks
Change in total fat mass (kg)
Measured: During 40 weeks
Waist circumference change (cm)
Measured: During 40 weeks
Body weight change (kg)
Measured: During 40 weeks
Glycated hemoglobin change (%)
Measured: During 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-diabetic ObesityStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863363
- Sponsor's protocol ID
- GS24-B046-401
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel-controlled Clinical Trial Comparing the Efficacy and Safety of PEG-rhGH Injection Combined with Semaglutide Injection Versus Semaglutide Injection Monotherapy in Body Composition of Non-Diabetic Obese Adults
- ClinicalTrials.gov ID
- NCT06863363
- Acronym / sponsor ID
- GS24-B046-401
- Conditions
- Non-diabetic Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- First posted
- 7 Mar 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 study aims to evaluate the efficacy and safety of PEG-rhGH Injection combined with Semaglutide Injection versus Semaglutide Injection monotherapy in improving body composition (lean body mass, fat mass, etc.) in non-diabetic obese adults, while also analyzing changes in body weight, blood glucose, and other metabolic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhGH Injection + Semaglutide Injection | Experimental | Drug: PEG-rhGH Injection + Semaglutide Injection |
| Semaglutide Injection | Active comparator | Drug: Semaglutide Injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 years (minimum age) and 50 years (maximum age), inclusive
- Gender: Male or female, with a ratio of male to female being 2:1;
- Body Mass Index (BMI) ≥28 kg/m²;
- No prior use of semaglutide injection or antidiabetic medications;
- Free Thyroxine (FT4) levels within normal range at screening;
Key exclusion criteria (30 listed)
- Unable to accept regular follow-up;
- Those who have difficulty with self-injection;
- Weight change >5.0% in the 12 weeks prior to screening (self-reported);
- History of allergic reactions to the study drug or similar drugs;
- Evaluated by the investigator as unable to tolerate subcutaneous injection, such as those undergoing anticoagulant therapy, thrombocytopenia, known bleeding disorders, or idiopathic thrombocytopenic purpura;
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 |
|---|---|---|
| PEG-rhGH Injection + Semaglutide InjectionPolyethylene Glycol Recombinant Human Growth Hormone Injection (PEG-rhGH Injection), 54 IU/9.0 mg/1.0 mL/amp.; Subcutaneous injection using pen-injector, once weekly at a dose of 2 mg per week (weeks 1-40). Semaglutide Injection, 0.68 mg/mL，1.5 mL；1.34 mg/mL，1.5 mL；1.34 mg/mL，3 mL；2.27 mg/mL，3 mL；3.2 mg/mL，3 mL; Subcutaneous injection once weekly using pre-filled pen including dosage escalation period (W1-W16): starting dose 0.25 mg, increasing every 4 weeks (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) and maintenance treatment period (W17-W40): at a dose of 2.4 mg for 24 weeks | Drug | PEG-rhGH Injection + Semaglutide Injection |
| Semaglutide InjectionSemaglutide Injection, 0.68 mg/mL，1.5 mL；1.34 mg/mL，1.5 mL；1.34 mg/mL，3 mL；2.27 mg/mL，3 mL；3.2 mg/mL，3 mL; Subcutaneous injection once weekly using pre-filled pen including dosage escalation period (W1-W16): starting dose 0.25 mg, increasing every 4 weeks (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) and maintenance treatment period (W17-W40): at a dose of 2.4 mg for 24 weeks | Drug | Semaglutide Injection |
Primary outcome
The change in lean body weight (kg) from baseline
Time frame: Week 40
10 secondary outcomes
Change in lean body mass percentage (%)
Time frame: During 40 weeks
Change in appendicular muscle mass (kg)
Time frame: During 40 weeks
Change in trunk muscle mass (kg)
Time frame: During 40 weeks
Change in appendicular fat mass (kg)
Time frame: During 40 weeks
Change in trunk fat mass (kg)
Time frame: During 40 weeks
Percentage change in total fat mass (%)
Time frame: During 40 weeks
Change in total fat mass (kg)
Time frame: During 40 weeks
Waist circumference change (cm)
Time frame: During 40 weeks
Body weight change (kg)
Time frame: During 40 weeks
Glycated hemoglobin change (%)
Time frame: During 40 weeks
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 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Lin ZHAO contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG-rhGH Injection + Semaglutide Injection and Semaglutide Injection in people with Non-diabetic Obesity, run by Shanghai Zhongshan Hospital 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 8 inclusion and 30 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: opening soon, as of the sponsor's last update on 7 Mar 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xiaoying LI, doctor (+86 136 5191 3857, xiaoying_li@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in lean body weight (kg) from baseline (time frame: Week 40). 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 7 Mar 2025.