Phase 1
N=32
Effect of a Ghrelin Receptor Agonist on Muscle and Bone
Sarcopenia · Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT04021706 ↗Enrolled (actual)
32
Serious AEs
6.3%
Results posted
Mar 2024
Primary outcome: Primary: Total Body Muscle Mass — 21.8; 20.8; 22.2; 20.8 kg units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Anamorelin Hydrochloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Body Muscle Mass |
21.8; 20.8; 22.2; 20.8 | — |
| SECONDARY Serum Procollagen 1 Intact N-terminal (P1NP) |
42.0; 45.9; 74.1; 46.2 | — |
| SECONDARY Fasting Plasma Glucose |
95; 100; 102; 97 | — |
| SECONDARY Serum Aspartate Transaminase (AST) |
23.2; 17.9; 21.8; 17.8 | — |
| SECONDARY Alanine Transaminase (ALT) |
16.8; 17.8; 15.8; 15.9 | — |
| SECONDARY Number of Participants With Symptoms and Any Adverse Events |
1; 0; 2; 0 | — |
| SECONDARY Appendicular Lean Mass (ALM) |
20.8; 18.3; 20.8; 18.0 | — |
Summary
Adults with low muscle mass also usually have low bone mass, making them vulnerable to falls, fractures and other injuries. This project will determine the effectiveness of treatment with a ghrelin receptor agonist in improving short term indicators of muscle and bone health in adults with low bone and muscle mass. The results of this trial will inform the design of a larger, definitive randomized trial designed to establish efficacy.
Eligibility Criteria
Inclusion Criteria
- 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 21
Exclusion Criteria
- BMI > 30 kg/m2 (obese are ineligible because anamorelin may cause weight gain)
- Osteoporosis of the spine or hip by DXA scan (specifically, T-score ≤ -2.5 at two lumbar vertebrae or at the total hip or femoral neck, as recommended by the International Society for Clinical Densitometry [ISCD])
- Current participation in a fitness program or weight loss program
- Advanced knee osteoarthritis (OA) or other conditions preventing strength or function testing
- Lower extremity fracture in the last year
- Diabetics taking insulin or sulfonylureas and subjects with a fasting blood sugar on screening >150 mg/dl
- Inadequate hepatic function defined as AST and ALT levels > 2 x upper limit of normal at screening (>74 and >68 MU/ml, respectively)
- Untreated thyroid or parathyroid disease
- Significant immune disorder
- eGFR 10 days in the last 3 mo)
- Gonadal hormones (vaginal estrogen okay)
- Drugs to promote weight loss or gain
- TNF-α inhibitors (e.g., adalimumab, adalimumab-atto, certolizumab pegol, etanercept, etanercept-szzs, golimumab, infliximab)
Data sourced from ClinicalTrials.gov (NCT04021706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.