Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy

NCT07336797 | Recruiting Phase 2 DMC

• 1 other identifier: CL(3828)
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

We investigate the role of empagliflozin in the treatment of obesity in PLWH.

Conditions

Metabolic Syndrome; Obesity & Overweight; HIV (Human Immunodeficiency Virus)

Keywords

Obesity; Empagliflozin; PLWH; HIV; SGLT-2 inhibitor; Metabolic Syndrome; Weight

Outcome Measures

Primary Outcomes (1)

• Weight change

  Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.

  6 months

Secondary Outcomes (9)

• Change in Total Cholesterol

  6 months

• Change in Fasting Blood Glucose

  6 months

• Change in Glycated Hemoglobin (HbA1c)

  6 months

• Change in Serum Creatinine

  6 months

• Change in Systolic and Diastolic Blood Pressure

  6 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients in the control group will receive an identical placebo and Standard Antiretroviral Therapy (ART)

Drug: Placebo

EMPA Group + SOC

EXPERIMENTAL

Patients in the intervention arm will receive Empagliflozin 10 mg once daily for 6 months in addition to the standard DTG-based antiretroviral therapy.

Drug: Empagliflozin (oral)

Interventions

Empagliflozin (oral) DRUG

Empagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys. This prevents glucose reabsorption, causing excess sugar to be excreted in urine. It helps lower blood sugar levels and can also reduce body weight and blood pressure.

Also known as: Mellitofix 10 mg

EMPA Group + SOC

Placebo DRUG

TDF/FTC+DLG

Also known as: Group A, Inactive Substance

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years up to 65 years old.
• Body Mass Index (BMI) \> 30 kg/m\^2.
• Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).
• Sustained virologic suppression, defined as HIV-1 RNA \< 200 copies/mL for at least 6 months.
• Current CD4 count \> 250 cells/mL.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level \> 126 mg/dL or glycated hemoglobin (HbA1c) \> 6.5% (or per ADA definition).
• Renal impairment (e.g., eGFR \< 60 ml/min/1.73m\^2).
• Active viral hepatitis B or C.
• Hypersensitivity to empagliflozin or any of its excipients.
• Pregnancy or breastfeeding.
• Current use of other SGLT-2 inhibitors.
• Drugs that may interact with empagliflozin (e.g., rifampin or phenytoin) or dolutegravir (e.g., antacids, carbamazepine, or phenytoin).
• Current or recent use of medications known to be associated with significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers, or other agents with established weight-promoting effects).
• Known thyroid disease, defined as TSH \> 6.0 mIU/L or \< 0.35 mIU/L

Sponsors & Collaborators

• Abdelrahman Mahmoud: lead

Study Sites (1)

Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Overweight; Acquired Immunodeficiency Syndrome; Body Weight

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Maggie Abbassi, Prof.

  Cairo University

  STUDY DIRECTOR

• Abedalrahman Dosoky

  Cairo University

  PRINCIPAL INVESTIGATOR

• Ahmed Kamel

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Abdelrahman Dosoky, Bachelor's degree

CONTACT

+201148534951; abdelrahman.ibrahim@pharma.cu.edu.eg

Ahmed Kamel, PhD

CONTACT

+20 100 676 6275; ahmedm.kamel@pharma.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching and Research Assistant

Model Details: This is a Phase II, single-center, parallel-group, randomized, double-blind, controlled study design. PWH will be recruited from the Cairo University HIV Clinic.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 13, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months

Locations

EG (1)