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Efficacy and Safety of Oral Semaglutide for Weight Control in Overweight or Obese HIV Patients Receiving Long-Term Integrase Inhibitor–Based Antiretroviral Therapy: A Multicenter, Prospective Cohort Study

Efficacy and Safety of Oral Semaglutide for Weight Control in Overweight or Obese HIV Patients Receiving Long-Term Integrase Inhibitor–Based Antiretroviral Therapy: A Multicenter, Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120002
Enrollment
Unknown
Registered
2026-03-06
Start date
2026-03-06
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Oral Semaglutide Group:None
Non-Semaglutide Group:None

Sponsors

Beijing Ditan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Treatment Group (Oral Semaglutide Group): 1.Confirmed HIV-positive status. 2.Currently receiving integrase strand transfer inhibitor (INSTI)–based HAART for more than 6 months. 3.Aged 18–60 years. 4.Undetectable HIV viral load. 5.Body mass index (BMI) >= 24.0 kg/m^² (overweight or obesity). 6.Abnormal glucose metabolism, defined as one of the following: Impaired fasting glucose (IFG): fasting plasma glucose (FPG) 6.1–7.0 mmol/L and 2-hour post–oral glucose load plasma glucose =7.0 mmol/L, or random venous plasma glucose or 2-hour post–oral glucose load plasma glucose >= 11.1 mmol/L, or glycated hemoglobin (HbA1c)>= 6.5%. 7.Receiving oral semaglutide. Control Group (Non-Semaglutide Group): 1.Confirmed HIV-positive status. 2.Currently receiving integrase strand transfer inhibitor (INSTI)–based HAART for more than 6 months. 3.Aged 18–60 years. 4.Undetectable HIV viral load. 5.Body mass index (BMI) >=24.0 kg/m^² (overweight or obesity) 6.Abnormal glucose metabolism, defined as one of the following: Impaired fasting glucose (IFG): fasting plasma glucose (FPG) 6.1–7.0 mmol/L and 2-hour post–oral glucose load plasma glucose =7.0 mmol/L, or random venous plasma glucose or 2-hour post–oral glucose load plasma glucose >= 11.1 mmol/L, or glycated hemoglobin (HbA1c) >= 6.5%. 7.Not receiving oral semaglutide.

Exclusion criteria

Exclusion criteria: 1.Presence of severe primary diseases of the heart, liver, kidney, or hematopoietic system. 2.Pregnancy or lactation, or women of childbearing potential who are unwilling or unable to use effective contraception as required.

Design outcomes

Primary

MeasureTime frame
Efficacy Indicators;Inflammatory Markers;

Secondary

MeasureTime frame
Safety Indicators;

Countries

China

Contacts

Public ContactXiao Jiang

Beijing Ditan Hospital, Capital Medical University

shawjiang@163.com+86 10 8432 2258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026