WILGO RESEARCH INDEX

Ipamorelin

Ipamorelin is a growth-hormone secretagogue and ghrelin-receptor agonist studied in healthy volunteers and in a randomized phase 2 postoperative-ileus trial. Human data demonstrate pharmacologic activity, but the phase 2 efficacy trial did not meet its key efficacy endpoint.

Ghrelin receptor agonistGH secretagogueHuman PK/PDPhase 2 trialNegative efficacy endpoint

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EVIDENCE MAP

What kind of evidence exists?

Ipamorelin is useful for the index because the human record includes both clear pharmacodynamic activity and a negative clinical efficacy result.

Healthy-volunteer pharmacologyDose-escalation work modeled ipamorelin exposure and GH response.

Randomized clinical evidenceA multicenter phase 2 trial enrolled bowel-resection patients with postoperative ileus.

Efficacy findingThe key endpoint—time to a tolerated solid meal—was not significantly different from placebo.

Safety contextThe phase 2 study described the tested regimen as well tolerated, but that does not establish unrestricted safety outside the trial setting.

A biologically active peptide can still fail a clinical endpoint.

Ipamorelin stimulated GH in human pharmacology research, yet the postoperative-ileus trial did not show a statistically significant improvement in its primary efficacy outcome.

PUBLISHED LITERATURE

Selected studies.

Selected sources are grouped by study type so model limitations remain visible.

HUMAN · PK/PD

Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers

1999 · PMID 10496658 · DOI 10.1023/A:1018955126402

Healthy male volunteers received escalating infusion rates, allowing investigators to model ipamorelin pharmacokinetics and its growth-hormone pharmacodynamic response.

PUBMED →DOI →

HUMAN · PHASE 2 RANDOMIZED

Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients

2014 · PMID 25331030 · DOI 10.1007/s00384-014-2030-8

In 117 enrolled patients, median time to a tolerated solid meal was shorter numerically with ipamorelin but not statistically significant versus placebo (p=0.15); secondary efficacy analyses also did not establish a significant benefit.

PUBMED →DOI →

REFERENCES

Primary sources.

Direct PubMed links are used wherever possible.

Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers1999 · PMID 10496658 · DOI 10.1023/A:1018955126402 · PubMed →

Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients2014 · PMID 25331030 · DOI 10.1007/s00384-014-2030-8 · PubMed →

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