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Smr3.5

Sermorelin Research

Mostly mechanism / observationalLimited safety

10 peer-reviewed studies

What the evidence says

Mostly mechanism / observational

Most Sermorelin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.

Most evidence is from mixed-quality randomised trials published 1986–2005 with a typical study size of 19 participants.

Based on 10 studies · 6 RCTs · 257 total participants

Confidence

Moderate

By outcome

Growth hormone axis & GH deficiency
Mostly mechanism / observational10 studies
Aging & GH-axis restoration
Mostly mechanism / observational4 studies
Safety profile
Too few graded studies1 study

Older research base

Newest study from 2005

198619952005

1Open-Labeln=110 · medium study1996

GHRH administered as a once daily dose of 30 micrograms/kg GHRH-(1-29), s.c., was effective in increasing height velocity in GH-deficient children.

Thorner M, Rochiccioli P, Colle M, Lanes R, et al. · J Clin Endocrinol Metab (1996)

Multicenter open-label study of 110 previously untreated prepubertal GH-deficient children given 30 µg/kg/day GHRH(1-29) sc at bedtime for up to 1 year
Mean height velocity rose from 4.1 cm/yr at baseline to 7.2 cm/yr at 12 months; 74% rated good responders at 6 months
No adverse changes in glucose or excessive IGF-1 generation; overall well tolerated

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2RCTn=43 · small study1993

Height velocity during treatment was lowest in the LD group, but comparable in the HD and GH groups.

Neyzi O, Yordam N, Ocal G, Bundak R, et al. · Acta Paediatr Suppl (1993)

Randomized comparison in 43 prepubertal children with hypothalamic GH deficiency: low-dose (30 µg/kg/day) vs high-dose (60 µg/kg/day) GHRH(1-29) vs recombinant GH for 6 months
An increase in height velocity of ≥2 cm/yr occurred in all but two children
Height velocity on high-dose GHRH(1-29) was comparable to GH, but an increase in height SDS for bone age occurred only in the GH-treated group

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3Review1986

Several analogues of GHRH have been shown to be safe, sensitive and specific stimuli to GH release.

Grossman A, Savage MO, Besser GM. · Clin Endocrinol Metab (1986)

Review of GHRH biology: the active C-terminal-shortened derivatives (including the 29-residue fragment) retain GH-releasing activity
Exogenous GHRH specifically increases circulating GH and may increase growth long-term
Many children with GH deficiency respond to intravenous GHRH with an acute rise in serum GH

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4RCTn=32 · small study2005

Administration of PEG-GHRH generated a clear increase in circulating GH compared with placebo... Some impairment of glucose tolerance was observed in the elderly following repeated administration.

Munafo A, Nguyen TX, Papasouliotis O, Lécuelle H, et al. · Eur J Endocrinol (2005)

Phase I randomized placebo-controlled trial of a PEGylated GHRH (designed to extend the short GHRH(1-29) half-life) in 12 young men and 20 elderly men/women
Subcutaneous dosing raised circulating GH and IGF-1 vs placebo; injection-site reactions were mild and transient
Repeated dosing in the elderly impaired glucose tolerance — a relevant safety signal for GH-axis stimulation

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5Open-Labeln=16 · very small study1988

Growth hormone remains the treatment of choice in growth hormone insufficiency.

Smith PJ, Brook CG. · Arch Dis Child (1988)

16 prepubertal GH-insufficient children treated with subcutaneous GHRH (1-40 and 1-29) for ~9 months each
73% (GHRH 1-40) and 63% (GHRH 1-29) showed a growth response; double the GHRH 1-29 dose was needed to match pulsatile GHRH 1-40
Response to conventional GH treatment was significantly better than GHRH, and height velocity improved when children were switched to GH

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6RCTn=19 · very small study1997

The use of GHRH or its analogs may be an alternative mode for restoring the GH-IGF-I axis in aging individuals.

Khorram O, Laughlin GA, Yen SS. · J Clin Endocrinol Metab (1997)

Single-blind, randomized, placebo-controlled 5-month trial in 19 adults aged 55-71, self-injecting [Nle27]GHRH(1-29)-NH2 10 µg/kg nightly
Tested whether restoring the GH/IGF-1 axis in aging is feasible with a GHRH analog rather than recombinant GH
Frames the aging/'anti-aging' question as a hypothesis about GH-axis restoration — not a demonstration of clinical anti-aging benefit

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7RCTn=19 · very small study1997

Restoration of this axis in age-advanced individuals, by the administration of GHRH, may enhance immune cell function.

Khorram O, Yeung M, Vu L, Yen SS. · J Clin Endocrinol Metab (1997)

Single-blind randomized placebo-controlled 5-month trial in 19 elderly adults given [Nle27]GHRH(1-29)-NH2 10 µg/kg nightly
Examined lymphocyte subsets, NK-cell number/cytotoxicity, mitogen responses, and IL-2 measures alongside IGF-1
Explored an immune-restoration hypothesis tied to GH/IGF-1 axis support in aging

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8RCTn=10 · very small study2000

Significantly lower peak and area under the curve (AUC) GH concentrations occurred in the irradiated group.

Achermann JC, Brook CG, Hindmarsh PC. · Eur J Endocrinol (2000)

Randomized controlled study comparing GHRH(1-29)NH2 dose-response (0.05, 0.15, 1.0 µg/kg iv) in 5 post-cranial-irradiation GH-insufficient adults vs 5 matched controls
Irradiated patients had significantly lower peak and AUC GH responses at clinically relevant doses
Refines the diagnostic use of GHRH(1-29) and the pathophysiology of post-radiotherapy GH insufficiency

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9RCTn=8 · very small study1995

Peak GH levels in response to GHRH1-29NH2, GHRP-2 and the combined... administrations were observed between 20 and 45 minutes.

Tiulpakov AN, Brook CG, Pringle PJ, Peterkova VA. · Clin Endocrinol (Oxf) (1995)

Randomized crossover pharmacodynamic study in 8 healthy adult men comparing GHRH(1-29)NH2, GHRP-2, and their combination (each 1 µg/kg iv)
GHRH(1-29) produced a clear GH peak at 20-45 minutes, though lower than GHRP-2 or the combination
Characterizes the magnitude and time-course of the GH response to GHRH(1-29) in healthy adults

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10Open-Label1986

It is proposed that GRF testing could provide a useful additional tool in the diagnosis of hGH deficiency.

Ranke MB. · Acta Paediatr Scand Suppl (1986)

Early clinical experience with synthetic GHRH(1-29) (GRF) in healthy volunteers and children with various disorders
Healthy subjects secreted GH up to ~40 ng/ml; GH-deficient children showed much lower responses than non-deficient children
Low false-positive rate supported GHRH testing as a diagnostic tool for GH deficiency

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View in Research Library

Sermorelin Research

Mostly mechanism / observational

Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group.

Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone.

Growth hormone releasing hormone.

Polyethylene glycol-conjugated growth hormone-releasing hormone is long acting and stimulates GH in healthy young and elderly subjects.

Growth hormone releasing hormone or growth hormone treatment in growth hormone insufficiency?

Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women.

Effects of [norleucine27]growth hormone-releasing hormone (GHRH) (1-29)-NH2 administration on the immune system of aging men and women.

The GH response to low-dose bolus growth hormone-releasing hormone (GHRH(1-29)NH2) is attenuated in patients with longstanding post-irradiation GH insufficiency.

GH responses to intravenous bolus infusions of GH releasing hormone and GH releasing peptide 2 separately and in combination in adult volunteers.

Clinical experience with GRF.