Trial · Interventional
Status unknownPhase 4Registry dataShort name LIROH
South Africa
1 trial
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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 kg/m2 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 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0 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.
Experimental
Lirgalutide
Following individual informed consent, all participants will undergo a series of basic cardiometabolic labs. They will then be initiated on liraglutide 0.6 mg administered subcutaneously, and this dose will be gradually increased over a period of 4 weeks to a dose of 3.0mg 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.
Outcomes the sponsor listed as primary.
Proportion of participants who screen and enroll among those approached
Time frame · Measured at screening
This will be expressed in terms of the proportion of participants who attend screening and enrolment visits among the total number who are approached regarding interest in study participation.
Time to reach study enrollment target
Time frame · Measured at enrollment
Study retention rate at 12 weeks
Time frame · Measured at Visit 4 at 12 weeks
This will be expressed as a proportion of participants who remain in the study after the 12 week "on treatment" period among those enrolled.
Study retention rate at 24 weeks
Time frame · Measured at End of Study at 24 weeks
This will be expressed as a proportion of participants who remain in the study after the full 24 weeks of study procedures are completed among those enrolled.
Rate of adherence to treatment over 12 weeks
Time frame · Measured at Visit 4 at 12 weeks
The investigators will assess volume remaining in the injector pens and provide a percentage of doses per participant that remained unused at the end of the 12-week period on treatment.
Embedded qualitative interviews regarding the acceptability of liraglutide for obesity management
Time frame · Measured at End of Study at 24 weeks
This will be open-ended responses to a brief exit interview about acceptability and feasibility.
Incidence of treatment-emergent adverse events as defined in this protocol
Time frame · From the initiation of treatment until the date of a treatment-emergent adverse event, assessed up to 24 weeks.
The investigators will report incidence of TEAEs up to 24 weeks (12 weeks on + 12 weeks off treatment)
Incidence of serious adverse events (SAEs), as defined in this protocol
Time frame · From the initiation of treatment until the date of a serious adverse event, assessed up to 24 weeks.
The investigators will report incidence of SAEs up to 24 weeks (12 weeks on + 12 weeks off treatment)
Change in body weight following 12 weeks on treatment
Time frame · Measured at Visit 4 at 12 weeks
Body weight will be measured in the study at both enrolment and after 12 weeks on treatment (Visit 4); these will be used to calculate a continuous change in kg.
Change in body weight over 24 weeks (12 weeks on + 12 weeks off treatment)
Time frame · Measured at End of Study at 24 weeks
Body weight will be measured in the study at both enrolment and after 24 weeks on treatment (EOS); these will be used to calculate a continuous change in kg.
Change in HbA1c following 12 weeks on treatment
Time frame · Measured at Visit 4 at 12 weeks
HbA1c will be measured at enrolment and at Visit 4; here investigators will calculate the difference between these measures (in %).
Change in HbA1c over 24 weeks (12 weeks on + 12 weeks off treatment)
Time frame · Measured at End of Study at 24 weeks
HbA1c will be measured at enrolment and at EOS; here investigators will calculate the difference between these measures (in %).
Change in fasting plasma glucose following 12 weeks on treatment
Time frame · Measured at Visit 4 at 12 weeks
Fasting glucose will be measured at enrolment and at Visit 4; investigators will calculate the difference between these measures (in mmol/L).
Change in fasting plasma glucose over 24 weeks (12 weeks on + 12 weeks off treatment)
Time frame · Measured at End of Study at 24 weeks
Fasting glucose will be measured at enrolment and at EOS; investigators will calculate the difference between these measures (in mmol/L).
Change in depressive symptoms following 12 weeks on treatment
Time frame · Measured at Visit 4 at 12 weeks
This will be defined as the difference in depression score per the Patient Health Questionnaire (PHQ-9) at enrolment and Visit 4. The minimum value is 1 and the maximum is 27, where the greater the total score, the greater severity of depression.
Change in depressive symptoms over 24 weeks (12 weeks on + 12 weeks off treatment)
Time frame · Measured at End of Study at 24 weeks
This will be defined as the difference in depression score per the Patient Health Questionnaire (PHQ-9) at enrolment and EOS. The minimum value is 1 and the maximum is 27, where the greater the total score, the greater severity of depression.
Change in physical activity level following 12 weeks on treatment
Time frame · Measured at Visit 4 at 12 weeks
This will be defined as the difference in physical activity expressed in MET-minutes per week, where MET minutes represent the amount of energy expended carrying out physical activity, per the International Physical Activity Questionnaire (IPAQ) at enrolment and Visit 4.
Change in physical activity level over 24 weeks (12 weeks on + 12 weeks off treatment)
Time frame · Measured at End of Study at 24 weeks
This will be defined as the difference in physical activity expressed in MET-minutes, where MET minutes represent the amount of energy expended carrying out physical activity, per week per the International Physical Activity Questionnaire (IPAQ) at enrolment and EOS.
Change in dietary habits following 12 weeks on treatment
Time frame · Measured at Visit 4 at 12 weeks
This will be defined as the difference in total servings of fruits and vegetables, change in frequency of sugar-sweetened beverage intake, and change frequency of fast food intake from enrolment to Visit 4.
Change in dietary habits over 24 weeks (12 weeks on + 12 weeks off treatment)
Time frame · Measured at End of Study at 24 weeks
This will be defined as the difference in total servings of fruits and vegetables, change in frequency of sugar-sweetened beverage intake, and change frequency of fast food intake from enrolment to EOS.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
Indexing hint: Randomized controlled trial · 2022
Rubino et al. 2022JAMAcited by 749
PMID 35015037PMC8753508DOI 10.1001/jama.2021.23619PUB-35015037
Indexing hint: Randomized controlled trial · 2021
Wilding et al. 2021The New England journal of medicinecited by 3,862
PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185
Indexing hint: Randomized controlled trial · 2021
Wadden et al. 2021JAMAcited by 858
PMID 33625476PMC7905697DOI 10.1001/jama.2021.1831PUB-33625476
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