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Effect of GLP-1RA preparation on gonadal function in overweight or obese patients and its related mechanism

Effect of GLP-1RA preparation on gonadal function in overweight or obese patients and its related mechanism

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126714
Enrollment
Unknown
Registered
2026-06-15
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or obesity

Interventions

Obesity or overweight observation group:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 60 years old (inclusive of the threshold value, based on the date of signing the informed consent form); 2. Gender is not restricted; 3. Body Mass Index (BMI) >= 24 kg/m^2 and = 28 kg/m^2 (comorbidities include endocrine and metabolic systems such as type 2 diabetes, lipid disorders, hyperuricemia; respiratory system such as obstructive sleep apnea syndrome; cardiovascular system such as coronary atherosclerotic heart disease, hypertension; urinary system such as chronic kidney disease, stress urinary incontinence; reproductive system such as polycystic ovary syndrome; digestive system such as gastroesophageal reflux disease, metabolic dysfunction-related fatty liver; skeletal and movement system such as osteoarthritis; psychological disorders such as depression, anxiety, etc.); 4. Selected from patients who have used telaprevir; 5. From the date of signing the informed consent until the study follow-up period, there is no intention to have children, and voluntarily take effective physical contraceptive measures, and no sperm donation plan; 6. The patient fully understands the purpose, nature, methods of the trial, as well as possible adverse reactions, voluntarily participates in this study, and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Screening for the history of using weight loss drugs within the past 3 months; 2. Screening for those who have used GLP-1 receptor agonists/antagonists or dipeptidyl peptidase IV inhibitors within the past 3 months; 3. Having a history of bariatric surgery; 4. Severe hypertension, with systolic blood pressure (SBP) >= 180 mmHg and/or diastolic blood pressure (DBP) >= 120 mmHg; 5. Having a history of acute or chronic pancreatitis, a symptomatic history of gallbladder disease (such as multiple gallbladder stones), a history of pancreatic injury, etc., which are high-risk factors that may cause pancreatitis; 6. Having a history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2A or 2B syndrome, or related family history; 7. Known to be allergic to the active ingredients of the study drug (GLP-1 and GLP-1RA); 8. Any other situation that the researcher considers may affect the patient's ability to provide informed consent or follow the trial protocol, or the patient's participation in the trial may affect the trial results or their own safety.

Design outcomes

Primary

MeasureTime frame
Changes of gonadal function indexes from baseline: including LH, FSH, estradiol, progesterone, prolactin, total testosterone, free testosterone and SHBG.;

Secondary

MeasureTime frame
Changes of body weight and body mass index (BMI) from baseline;

Countries

China

Contacts

Public ContactQing Miao

Huashan Hospital, Fudan University

miaoqing@huashan.org.cn+86 21 5288 7027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026