Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent weight regain from weeks 12-60 (microdosing period)
研究概览
简要总结
The objectives of this study are as follows:
Primary Objective
- To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs. no additional drug following induction therapy.
Secondary Objectives
- To evaluate the tolerability of semaglutide microdosing in adults with HIV.
- To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed human immunodeficiency virus type 1 (HIV-1)
- •On antiretroviral therapy (ART) for greater than or equal to 24 weeks prior to entry and no change in regimen in the 12 weeks prior to entry or planned change for the study duration
- •HIV-1 ribonucleic acid (RNA) <200 copies/mL at screening
- •BMI greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 if also with greater than or equal to 1 weight-related comorbidity
- •If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for greater than or equal to 12 weeks prior to entry and no plans to dose escalate for the study duration
- •All participants must be willing and able to provide written informed consent and undergo all required study procedures
排除标准
- •Weight greater than or equal to 400 pounds [due to dual X-ray absorptiometry (DXA) machine limitations] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry
- •Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded)
- •Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period
- •Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period
- •Active eating disorder
- •Use of human growth hormone, tesamorelin or anabolic steroids <12 weeks prior to entry, unless on a stable dose for >24 weeks prior to entry, or plans to start any of these medications while on study
- •Active, severe delayed gastric emptying
- •Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study
- •Known retinopathy
- •Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- •Untreated, poorly controlled or previously undiagnosed thyroid disease
- •Chronic pancreatitis
- •Known allergy/sensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA)
- •Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) <0.5 or >10 milli-international units per liter (mIU/L) at screening
- •Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- •Pregnancy, nursing or plans for either during the study period
- •Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period
- •Current serious illness requiring systemic treatment and/or hospitalization, in the opinion of site investigator
研究组 & 干预措施
Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60.
干预措施: Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly (Drug)
Dose escalation to 2 mg semaglutide weekly then no semaglutide
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60.
干预措施: Dose escalation to 2 mg semaglutide weekly then no semaglutide (Drug)
结局指标
主要结局
Percent weight regain from weeks 12-60 (microdosing period)
时间窗: from week 12 to week 60
The percent weight regain from weeks 12-60 (microdosing period), calculated as the median within-person: change in weight (kg) from weeks 60-12 (microdosing period) divided by the change in weight (kg) from weeks 12-0 (dose escalation period).
次要结局
- Percent change in minimum waist circumference(Baseline, 12 weeks, 60 weeks)
- Tolerability of semaglutide microdosing in participants as indicated by total number of serious adverse events (SAEs) and adverse events (AEs)(From baseline through week 60)
- Absolute change in weight(Baseline, 12 weeks, 60 weeks)
- Percent change in weight(Baseline, 12 weeks, 60 weeks)
- Percent change in body mass index (BMI)(Baseline, 12 weeks, 60 weeks)
- Absolute change in minimum waist circumference(Baseline, 12 weeks, 60 weeks)
- Absolute change in body mass index (BMI)(Baseline, 12 weeks, 60 weeks)
研究者
Jordan Elizabeth Lake
Professor
The University of Texas Health Science Center, Houston