# Effect of a ghrelin receptor agonist on muscle and bone

> **NIH NIH R21** · TUFTS UNIVERSITY BOSTON · 2020 · $199,320

## Abstract

PROJECT SUMMARY
Adults with both osteopenia and sarcopenia (osteosarcopenia) have greater risk of falls and fractures than
those with osteopenia or sarcopenia alone. Drugs are available to reduce fracture risk but currently exercise is
the only effective strategy to combat muscle loss. Unfortunately, the majority of adults who start a self-
monitored exercise program drop out after 6 months and other options are needed. Ghrelin receptor agonists
have been under development to treat anorexia and weight loss in patients with cancer cachexia. The agonist
anamorelin has significantly increased weight and lean tissue mass in these patients. Anamorelin mimics the
hormone ghrelin which not only increases apatite, but also acts on the pituitary to increase pulsatile growth
hormone (GH) secretion. Pulsatile GH stimulates the production of insulin-like growth factor 1 which is anabolic
to both muscle and bone. GH levels decline with age and this is thought to contribute to the age-related muscle
and bone losses in adults. Our central hypothesis is that anamorelin will increase muscle mass, improve
muscle function, and increase bone formation in adults with osteosarcopenia. To test this hypothesis, we will
conduct a randomized, double-blind, 2-armed, parallel-group intervention trial in 40 osteosarcopenic men and
postmenopausal women age 50 and older. Participants will be randomized to anamorelin (100 mg per day) or
placebo and treated for 12 months. The primary endpoint is increase in appendicular lean tissue mass
measured by dual-energy x-ray absorptiometry. Secondary endpoints are: increases in muscle strength
(isometric leg strength) and function (6-minute walk and modified short physical performance battery), an
increase in the bone formation biomarker, amino-terminal propeptide (P1NP), and an increase in total lean
tissue mass. The proposed treatment supplies the anabolic stimulus to build both muscle and bone.
Anamorelin has not been tested in adults with osteosarcopenia. We propose to evaluate this treatment in
osteosarcopenic adults who are most in need of treatment and who are also most likely to benefit. Data
obtained from this pilot study are critical to determine the feasibility and guide the design of a definitive trial to
evaluate this ghrelin receptor agonist as potential therapy to mitigate the dual hazards of osteopenia and
sarcopenia.

## Key facts

- **NIH application ID:** 9910364
- **Project number:** 5R21AR074138-02
- **Recipient organization:** TUFTS UNIVERSITY BOSTON
- **Principal Investigator:** Bess Dawson-Hughes
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $199,320
- **Award type:** 5
- **Project period:** 2019-04-10 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9910364

## Citation

> US National Institutes of Health, RePORTER application 9910364, Effect of a ghrelin receptor agonist on muscle and bone (5R21AR074138-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9910364. Licensed CC0.

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