PEG-rhGH and Semaglutide Combination Therapy in Non-Diabetic Obese Adults

NCT06863363 | Not Yet Recruiting Phase 4

• 1 other identifier: GS24-B046-401
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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 metabolic parameters.

Conditions

Non-diabetic Obesity

Outcome Measures

Primary Outcomes (1)

• The change in lean body weight (kg) from baseline

  Week 40

Secondary Outcomes (10)

• Change in lean body mass percentage (%)

  During 40 weeks

• Change in appendicular muscle mass (kg)

  During 40 weeks

• Change in trunk muscle mass (kg)

  During 40 weeks

• Change in appendicular fat mass (kg)

  During 40 weeks

• Change in trunk fat mass (kg)

  During 40 weeks

Study Arms (2)

PEG-rhGH Injection + Semaglutide Injection

EXPERIMENTAL

Drug: PEG-rhGH Injection + Semaglutide Injection

Semaglutide Injection

ACTIVE COMPARATOR

Drug: Semaglutide Injection

Interventions

PEG-rhGH Injection + Semaglutide Injection DRUG

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

PEG-rhGH Injection + Semaglutide Injection

Semaglutide Injection DRUG

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 Injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

polyethylene glycol-recombinant human growth hormone; semaglutide

Central Study Contacts

Xiaoying LI, doctor

CONTACT

+86 136 5191 3857; xiaoying_li@hotmail.com

Lin ZHAO

CONTACT

13917902849

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 7, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02

Locations

CN (1)