Table 1.

Clinical trials for IGF-I and muscle therapy

Therapeutic Target	Subjects	IGF-I Isoform	Delivery Method	Outcome
Sarcopenia
	Elderly women (N=14)	rhIGF-I	15–60 ug/kg SQ BID 1 month	Increased whole body and muscle protein synthesis2
	Healthy, nonobese, postmenopausal women over 60 yr of age (N=16)	rhIGF-I	15 ug/kg SQ BID 1 year	No change in body composition, bone density, strength, or memory4
GH Deficiency
	Growth hormone deficient young adults (N=8)	rhIGF-I	60 ug/kg SQ BID 8 weeks	Increased fat-free mass and protein synthesis rates; no effect on skeletal muscle strength90
Muscle Wasting/Cachexia
	Patients with AIDS-associated wasting (N=60)	rhIGF-I and GH	0 or 5 mg IGF SQ BID 0 or 1.4 mg GH SQ 1D 12 weeks	Single and combined treatments increased lean body mass, with combined GH/rhIGF-I providing the most benefit; GH only improved muscle strength91
Diabetes/Metabolism
	Obese postmenopausal women (N=33)	rhIGF-I and GH	0 or 15 ug/kg IGF SQ BID 0 or 25 ug/kg GH SQ 1D 12 weeks	Enhanced fat loss92
	Type 2 diabetes mellitus subjects (N=8)	rhIGF-I	80 ug/kg SQ BID 7 days	Improved hepatic and muscle insulin sensitivity3
Neuromuscular Disease
	Amyotrophic lateral sclerosis (ALS) patients (N=266)	rhIGF-I	5 or 10 ug/kg SQ ID 9 months	Dose-dependent deceleration of pathological progression5
	Amyotrophic lateral sclerosis (ALS) patients (N=124)	rhIGF-1	10 ug/kg SQ ID 9 months	No significant differences in disease progression1
	Amyotrophic lateral sclerosis (ALS) patients (N=9)	rhIGF-I	0.5–3 μg/kg Intrathecal every 2 weeks for 40 weeks	Modest but significant beneficial functional effects8
	Amyotrophic lateral sclerosis (ALS) patients (N=330)	rhIGF-I	3 μg/kg SQ BID 2 years	No differences between treatment & placebo groups; Major effect of hypoglycemia9
	Myotonic dystrophy type 1 patients (N=15)	rhIGF-I/rhIGFBP3 (IPLEX)	0.5–2 mg/kg SQ 1D 24 weeks	Increased lean body mass; improved metabolism; no increased muscle strength93