Overview
The SLIM LIVER Study
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2023-08-30
2023-08-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the safety and tolerability of a drug called semaglutide and to see whether it can reduce IHTG. IHTG will be measured by magnetic resonance imaging (MRI; an MRI machine contains a powerful magnet that uses simple radio waves to take pictures of organs). Semaglutide (brand name Ozempic®) is a drug that is used to treat people who have diabetes; it also causes weight loss and may provide some protection against cardiovascular disease and diabetes. In PLWH, the use of semaglutide to reduce weight and the level of IHTG are experimental.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AIDS Clinical Trials GroupCollaborator:
National Institute of Allergy and Infectious Diseases (NIAID)Criteria
Inclusion Criteria:- Two separate reports of HIV-1 RNA measurements <50 copies/mL, and no HIV-1 RNA
measurement >500 copies/mL, during the 48 weeks prior to entry.
- No change in ART in 24 weeks prior to entry or plans to change during study.
- Not meeting criteria for diabetes but with central adiposity (i.e., minimum waist
circumference of ≥95 cm for individuals assigned male sex at birth or ≥94 cm for
individuals assigned female sex at birth), ≥5% IHTG content, plus at least one of the
following indicators of insulin resistance or pre-diabetes: fasting plasma glucose
100-125 mg/dL, HbA1c between 5.7% and <6.5%, or HOMA-IR >3.0.
- Documented evidence of immunity to hepatitis A virus (HAV) or documented history of
HAV vaccination within 30 days prior to entry.
- CD4+ T-cell count ≥200 cells/mm3 within 30 days prior to pre-entry.
- The following laboratory values obtained within 30 days prior to pre-entry:
1. Absolute neutrophil count (ANC) >750 cells/mm3.
2. Hemoglobin >10 g/dL for individuals assigned male sex at birth and >9 g/dL for
individuals assigned female sex at birth.
3. Creatinine clearance (CrCl) ≥50 mL/min, as calculated by the CKD-Epi equation.
4. Aspartate aminotransferase (AST) (SGOT) ≤3 x ULN on at least two measures.
5. Alanine aminotransferase (ALT) (SGPT) ≤3 x ULN on at least two measures.
6. Fasting triglyceride level ≤500 mg/dL.
- For individuals prescribed daily medications with anti-inflammatory properties, the
doses must be stable.
- For individuals taking daily lipid-lowering medications, the doses must be stable.
- Agree to use contraception if able to become pregnant.
- For individuals taking vitamin E (any dose), the dose must be stable.
Exclusion Criteria:
- Pregnant, breastfeeding, or plans to become pregnant.
- Known active hepatitis C virus (HCV) infection.
- Active/chronic hepatitis B virus (HBV).
- Known retinopathy (excluding remote history of cotton wool spots).
- Known active severe delayed gastric emptying.
- Gain or loss of >5% body weight within 12 weeks prior to study entry.
- Any plans to change diet or exercise regimen significantly, except for the adoption of
study-provided suggestions for diet and exercise, within the study period.
- Known acute or chronic liver disease with cirrhosis or portal hypertension.
- History of liver transplant.
- Current diagnosis of diabetes mellitus or current use of diabetes medications, or a
laboratory measurement of hemoglobin A1c ≥6.5% at screening.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia type 2 (MEN2).
- History of unexplained hypercalcemia corrected for albumin that is >10.5 mg/dL.
- Use of any immunomodulatory (including prednisone equivalent of ≥10 mg), HIV vaccine,
investigational therapy, or TNF-α therapy within 3 months prior to study entry.
- Use of human growth hormone, tesamorelin, supraphysiologic testosterone to achieve
therapeutic blood levels, or any use of other anabolic steroids within 3 months prior
to study entry or plans to start these while on study.
- Use of estrogens or progesterones at supraphysiologic doses within 3 months prior to
study entry.
- Known allergy/sensitivity or any hypersensitivity to components of study drug or its
formulation.
- Current serious illness requiring systemic treatment and/or hospitalization.
- Use of GLP-1 agonists within 24 weeks prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements.
- Excessive consumption of alcohol of ≥3 months within 90 days prior to screening.
- Known chronic pancreatitis or more than one episode of pancreatitis ever in the past.
- Intent to use any medication likely to cause significant changes in weight during the
study period.
- Use of stavudine within 12 months prior to study entry.
- Prior bariatric surgery (e.g., lap band, gastric sleeve, or Roux-en-Y bypass surgery)
or major gastric surgery or plans to undergo weight reduction surgery while on study.
- Individuals with any metal, implantable devices (e.g., pacemakers, prosthetics), or
shrapnel, per standard MRI exclusion criteria.