Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438146
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-02
Brief Title:
LIROH - Liraglutide for Obesity in HIV
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Liraglutide for Management of Obesity in People Living With HIV on Dolutegravir-based Antiretroviral Therapy a Single-arm Acceptability Study in South Africa
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIROH
Brief Summary:
The goal of this single-arm open label pilot study is to evaluate liraglutide at the recommended dosage administered subcutaneously lifestyle counselling for the management of people living with HIV PLWH with obesity defined by a BMI 30 kgm2 who are on dolutegravir-based ART
Following individual informed consent all participants will undergo a series of basic cardiometabolic labs They will then be initiated on liraglutide 06 mg administered subcutaneously and this dose will be gradually increased over a period of 4 weeks to a dose of 30 mg daily Alongside drug administration participants will receive lifestyle counselling regarding diet and physical activity Following completion of a 12-week on treatment period liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment Body weight cardiometabolic risk parameters and a suite of patient-reported outcomes regarding diet physical activity sleep and quality of life will be assessed periodically over the course of the study
Following individual informed consent all participants will undergo a series of basic cardiometabolic labs They will then be initiated on liraglutide 06 mg administered subcutaneously and this dose will be gradually increased over a period of 4 weeks to a dose of 30 mg daily Alongside drug administration participants will receive lifestyle counselling regarding diet and physical activity Following completion of a 12-week on treatment period liraglutide will be stopped and participants will be followed for an additional 12-weeks off treatment Body weight cardiometabolic risk parameters and a suite of patient-reported outcomes regarding diet physical activity sleep and quality of life will be assessed periodically over the course of the study
Detailed Description:
South Africa has the largest population of PLWH globally with a prevalence of 17 in adults or 72 million PLWH The rapid scale-up of ART programs has resulted in 6 million PLWH on treatment significant gains in life expectancy and a large population of aging PLWH With increasing life expectancy obesity and type 2 diabetes have become growing threats for PLWH in South Africa and globally One recent study found that 63 of PLWH are overweight or obese and 6 have diabetes in this setting
This elevated risk of obesity in PLWH in South Africa is likely due to a confluence of both general considerations and HIV-specific factors First South Africa has experienced an accelerated background epidemic of metabolic disease in the general population with a prevalence of overweight and obesity that is nearly equal to that of high-income countries Additionally the International Diabetes Federation estimates that approximately 155 million adults are living with diabetes in the African Region and projects it to grow to 41 million by 2045 As part of this background epidemic of metabolic disease South Africa is also experiencing a nutrition transition with widespread availability of processed and refined foods as well as sugar-sweetened beverages
Regarding HIV-specific issues in 2019 the first-line ART regimen for the South African national HIV treatment program transitioned to TLD TLD is generally very safe and well-tolerated and has a high barrier to HIV resistance but this transition to this regimen has been associated with risk of excess weight gain at the population level Both clinical trials and observational studies conducted in South Africa have shown substantial increases in body weight in those who are initiating this ART regimen newly and among those who are suppressed and switched especially women Given this there is a growing risk of obesity in PLWH in this context and a need for management strategies to address this increasingly prevalent comorbidity
Preventing the metabolic complications of HIV in South Africa and worldwide requires urgent solutions To date obesity management and diabetes prevention have largely consisted of behavioural interventions such as the Diabetes Prevention Program and related lifestyle modification efforts focused on improving diet and increasing physical activity However in the past several years novel anti-obesity pharmacologic agents such as the glucagon-like peptide-1 receptor agonists GLP-1 RAs have shown enormous promise for obesity management and diabetes prevention in people who are HIV-negative 8-10 However this drug class has a very limited evidence base in PLWH and relatively scant data from sub-Saharan African populations
Currently liraglutide is the only GLP-1 RA approved for obesity management in South Africa and this protocol proposes to use the drug for its labelled indication of weight loss in addition to diet and exercise in adults aged 18 and above who have 1 a BMI of 30 or greater obese or 2 a BMI of greater than 27 and less than 30 overweight and weight related health problems such as diabetes high blood pressure hypercholesterolemia or obstructive sleep apnoea
This evidence gap motivates further inquiry into GLP-1 RAs such as liraglutide as one potential approach to obesity management and prevention of diabetes in PLWH who have comorbid obesity in South Africa with implications for PLWH in other contexts In this proposal the investigators seek to further this important area of inquiry by evaluating the acceptability of liraglutide along with lifestyle counselling in PLWH who have obesity and are stable on dolutegravir-based ART in South Africa
This elevated risk of obesity in PLWH in South Africa is likely due to a confluence of both general considerations and HIV-specific factors First South Africa has experienced an accelerated background epidemic of metabolic disease in the general population with a prevalence of overweight and obesity that is nearly equal to that of high-income countries Additionally the International Diabetes Federation estimates that approximately 155 million adults are living with diabetes in the African Region and projects it to grow to 41 million by 2045 As part of this background epidemic of metabolic disease South Africa is also experiencing a nutrition transition with widespread availability of processed and refined foods as well as sugar-sweetened beverages
Regarding HIV-specific issues in 2019 the first-line ART regimen for the South African national HIV treatment program transitioned to TLD TLD is generally very safe and well-tolerated and has a high barrier to HIV resistance but this transition to this regimen has been associated with risk of excess weight gain at the population level Both clinical trials and observational studies conducted in South Africa have shown substantial increases in body weight in those who are initiating this ART regimen newly and among those who are suppressed and switched especially women Given this there is a growing risk of obesity in PLWH in this context and a need for management strategies to address this increasingly prevalent comorbidity
Preventing the metabolic complications of HIV in South Africa and worldwide requires urgent solutions To date obesity management and diabetes prevention have largely consisted of behavioural interventions such as the Diabetes Prevention Program and related lifestyle modification efforts focused on improving diet and increasing physical activity However in the past several years novel anti-obesity pharmacologic agents such as the glucagon-like peptide-1 receptor agonists GLP-1 RAs have shown enormous promise for obesity management and diabetes prevention in people who are HIV-negative 8-10 However this drug class has a very limited evidence base in PLWH and relatively scant data from sub-Saharan African populations
Currently liraglutide is the only GLP-1 RA approved for obesity management in South Africa and this protocol proposes to use the drug for its labelled indication of weight loss in addition to diet and exercise in adults aged 18 and above who have 1 a BMI of 30 or greater obese or 2 a BMI of greater than 27 and less than 30 overweight and weight related health problems such as diabetes high blood pressure hypercholesterolemia or obstructive sleep apnoea
This evidence gap motivates further inquiry into GLP-1 RAs such as liraglutide as one potential approach to obesity management and prevention of diabetes in PLWH who have comorbid obesity in South Africa with implications for PLWH in other contexts In this proposal the investigators seek to further this important area of inquiry by evaluating the acceptability of liraglutide along with lifestyle counselling in PLWH who have obesity and are stable on dolutegravir-based ART in South Africa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK125162 | NIH | None | httpsreporternihgovquickSearchK23DK125162 |