Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

NCT06554717 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024P001703
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in doing so than in the general population and is difficult to sustain in the long-term. The goal of this clinical trial is to learn whether the medication tesamorelin will improve physical function and muscle health in adults with HIV when combined with exercise. Tesamorelin is a growth hormone-releasing hormone analogue that is FDA-approved to treat abdominal fat accumulation in people with HIV. While tesamorelin has also been shown to increase muscle mass and improve measures of muscle health, its effects on physical performance and muscle strength have not yet been evaluated. During a 24-week intervention phase, half of participants will be randomly assigned to receive tesamorelin and half of participants will be randomly assigned to receive placebo (a look-alike substance that contains no drug). All participants also will engage in a home-based exercise intervention supervised by an exercise coach. During a subsequent 24-week extension phase, individuals will be monitored off study drug and supervised exercise, and be encouraged to continue to exercise independently. The investigators will investigate effects of tesamorelin on physical function, muscle mass and quality, quality of life, and exercise adherence and self-efficacy. They also will evaluate whether effects of tesamorelin are maintained following treatment cessation. This study may identify an important strategy to improve how individuals aging with HIV function and feel with potential applications to other patient populations.

Conditions

HIV-1-infection; Frailty; Impaired Physical Function; Abdominal Obesity; Aging

Outcome Measures

Primary Outcomes (1)

• Change in Repeated Chair Stand Time

  Time to complete 10 repeated chair stands

  Baseline to Week 24

Secondary Outcomes (11)

• Change in Standard and Modified Short Physical Performance Battery (SPPB)

  Baseline to Week 24

• Change in 1-Repetition Maximum Leg Press

  Baseline to Week 24

• Change in 400-Meter Walk Time

  Baseline to Week 24

• Change in Appendicular Lean Tissue Mass

  Baseline to Week 24

• Change in Cross-Sectional Area of Trunk and Thigh Muscles

  Baseline to Week 24

Study Arms (2)

Tesamorelin Plus Exercise

ACTIVE COMPARATOR

Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention

Drug: Tesamorelin; Behavioral: Exercise

Placebo Plus Exercise

PLACEBO COMPARATOR

Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention

Drug: Placebo; Behavioral: Exercise

Interventions

Tesamorelin DRUG

Tesamorelin WR 1.28 mg given subcutaneously daily

Also known as: Egrifta, TH9507, growth hormone-releasing hormone analogue

Tesamorelin Plus Exercise

Placebo DRUG

Identical placebo injection given subcutaneously daily

Placebo Plus Exercise

Exercise BEHAVIORAL

Home-based semi-supervised exercise program

Placebo Plus Exercise; Tesamorelin Plus Exercise

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 50-80 years old
• Documented HIV infection on suppressive antiretroviral therapy for at least 1 year with HIV-1 RNA \<200 copies/mL and CD4+ T cell count \>200/µL 3
• Sedentary lifestyle, defined as self-reported physical activity that breaks a sweat \<3 days/week with no regular resistance exercise in the past 3 months
• ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)
• Waist circumference ≥102 cm in men and ≥88 cm in women
• Normal mammogram within 2 years (females ≤74 years old) or prostate specific antigen \<4 ng/mL (males ≤70 years old) per U.S. Preventive Services Task Force (USPSTF) age-appropriate cancer screening guidelines
• For females, postmenopausal defined as no menses for ≥12 months and anti-müllerian hormone (AMH) \<20 pg/mL or history of bilateral oophorectomy at least 3 months ago
• Provider approval to participate

You may not qualify if:

• Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
• Insulin-like growth factor 1 (IGF-1) z-score \>2.0
• HbA1c \>8%
• Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months
• Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
• Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months
• Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia
• History of hypopituitarism, head irradiation, or other conditions known to affect the GH/IGF-1 axis
• Known hypersensitivity to tesamorelin or mannitol
• Acute or chronic illness judged by the investigator to represent a contraindication to study participation

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Colorado, Denver: collaborator

Study Sites (2)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Obesity, Abdominal

Interventions

tesamorelin; Ghrelin; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lindsay T. Fourman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Kristine M. Erlandson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay T. Fourman, MD

CONTACT

617-643-4590; lfourman@mgb.org

Kristine M. Erlandson, MD

CONTACT

303-724-4941; kristine.erlandson@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (2)