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Tests treatment safety and results for Obesity
Official title Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV
ClinicalTrials.gov ID: NCT04174755
What this study is testing
What is Semaglutide Injectable Product?
Semaglutide Injectable Product is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity.
Also referred to as Ozempic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be over 18 years old
- Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay
- Be stable on ART with a viral load suppressed \<40 copies/mL for a minimum of 2 years
- Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year
- Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus
You likely can't join if
- people unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide
- History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic...
- History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).
- Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within...
- History of severe renal impairment, as defined by a baseline creatinine clearance \<30ml/min
- Individuals with a diagnosis of HIV-associated lipoatrophy/lipodystrophy, based on physician's assessment
See the full eligibility criteria
- Be over 18 years old
- Be HIV-1 antibody positive as determined by a positive 4th generation Ag/Ab ELISA assay
- Be stable on ART with a viral load suppressed \<40 copies/mL for a minimum of 2 years
- Have a CD4 count ≥200 cells/mm3 for a minimum of 1 year
- Have a BMI ≥30kg/m2 or have a BMI ≥27kg/m2 and hypertension, dyslipidaemia or type 2 diabetes mellitus
- Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial
- people unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide
- History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma
- History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).
- Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin)
- History of severe renal impairment, as defined by a baseline creatinine clearance \<30ml/min
- Individuals with a diagnosis of HIV-associated lipoatrophy/lipodystrophy, based on physician's assessment
- Individuals with severe hepatic impairment (Child Pugh score \>9)
- people with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection
- Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study
- History of cancer (apart from treated Kaposi's Sarcoma) and/or receiving chemotherapy or radiotherapy
- Active illicit intravenous drug use
- people concurrently enrolled in another clinical trial of an investigational medicinal product.
- The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments
- people with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide
- people on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited/cautioned concomitant medications/therapies section)
- For female people: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Dublin, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Dublin, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.