Effect of a Ghrelin Receptor Agonist on Muscle and Bone

NCT04021706 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 30351R21AR074138-01A1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Osteopenia

Outcome Measures

Primary Outcomes (1)

• Total Body Muscle Mass

  to be assessed by D3-creatine dilution

  baseline and 12 months

Secondary Outcomes (6)

• Serum Procollagen 1 Intact N-terminal (P1NP)

  baseline and 12 months

• Fasting Plasma Glucose

  baseline and 12 months

• Serum Aspartate Transaminase (AST)

  baseline and 12 months

• Alanine Transaminase (ALT)

  baseline and 12 months

• Number of Participants With Symptoms and Any Adverse Events

  between baseline and 12 months

Other Outcomes (6)

• Handgrip Strength

  baseline and 12 months

• Isokinetic Leg Strength

  baseline and 12 months

• Health Aging and Body Composition-Physical Performance Battery

  baseline and 12 months

Study Arms (2)

anamorelin

ACTIVE COMPARATOR

one 100 mg tablet daily, taken one hour before breakfast

Drug: Anamorelin Hydrochloride

microcrystaline cellulose

PLACEBO COMPARATOR

one identical appearing tablet daily, taken one hour before breakfast

Drug: Placebo

Interventions

Anamorelin Hydrochloride DRUG

Ghrelin receptor agonist

anamorelin

Placebo DRUG

placebo is a inert substance

Also known as: microcrystalline cellulose

microcrystaline cellulose

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Osteopenia defined as spine (at L1, L2, L3, or L4) or total hip or femoral neck BMD T-score between -1.0 and -2.5
• Mini-mental state examination (MMSE) score \>21

You may not qualify if:

• 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\<30 ml/min
• Any clinically meaningful electrocardiogram (ECG) abnormality on screening or baseline
• Crohn's disease
• Active malignancy or cancer therapy in the last year
• Non-English speaking subjects (the investigators can't be confident that non-English speaking subjects could accurately complete the diet assessments which are critical to the integrity of the study)
• Allergy to components of the study interventions

Sponsors & Collaborators

• Tufts University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Sarcopenia; Bone Diseases, Metabolic

Interventions

anamorelin; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Bess Dawson-Hughes
• Organization: Tufts University

bess.dawson-hughes@tufts.edu

6175563066

Study Officials

• Bess Dawson-Hughes, MD

  Tufts University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Bone Metabolism Lab and Professor of Medicine

Model Details: double blind randomized controlled clinical trial

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 16, 2019
• Study Start: December 5, 2019
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)