Effect of a Ghrelin Receptor Agonist on Muscle and Bone

What Was Tested

This registered phase 1 trial tested Anamorelin (non-peptide) for osteoporosis and bone density.

Adults with low muscle mass also usually have low bone mass, making them vulnerable to falls, fractures and other injuries.

It had two arms (groups): anamorelin (active comparator) and microcrystaline cellulose (placebo comparator).

One identical appearing tablet daily, taken one hour before breakfast.

The registry classes the interventions as drug.

More on the Plan

Adults with both osteopenia and sarcopenia (osteosarcopenia) have greater risk of falls and fractures than those with osteopenia or sarcopenia alone.

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.

Pulsatile GH stimulates the production of insulin-like growth factor 1 which is anabolic to both muscle and bone.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Ability to sign informed consent form. Community dwelling individuals aged 50 years and older. Men (who are sterile or agree to use contraception throughout the study). Postmenopausal women (no menses for 5 years; early postmenopausal women are ineligible because their bone turnover rate is changing rapidly). Sarcopenia defined as maximum grip strength \<35.5 kg (men) and \<20 kg (women) in either hand (excluding hands with severe pain or recent surgery) and/or gait speed \<0.8 m/sec.

The full record lists 7 inclusion and 29 exclusion criteria; among the exclusions: BMI \> 30 kg/m2 (obese are ineligible because anamorelin may cause weight gain); current participation in a fitness program or weight loss program; lower extremity fracture in the last year.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Anamorelin (non-peptide) and who got the comparison, which limits bias.

The Anamorelin (non-peptide) group and the comparison group ran side by side rather than switching.

Neither the osteoporosis and bone density participants nor the staff measuring them knew who was on Anamorelin (non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-12-05 with completion listed for 2023-01-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Total Body Muscle Mass (time frame: baseline and 12 months).

It also tracked 6 secondary outcomes, for example Serum Procollagen 1 Intact N-terminal (P1NP), Fasting Plasma Glucose, Serum Aspartate Transaminase (AST), Alanine Transaminase (ALT), Number of Participants With Symptoms and Any Adverse Events and Appendicular Lean Mass (ALM).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Anamorelin (non-peptide) in 32 people with osteoporosis and bone density.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Anamorelin (non-peptide) compound page, Osteoporosis and bone density research.