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A Metabolite of a Ghrelin Receptor Drug Shows Its Own Ability to Block the Hunger Hormone System

evidence
The takeaway

The major metabolite of a ghrelin receptor-blocking drug (PF-5190457) itself demonstrates inverse agonist activity at the ghrelin receptor and suppresses food intake in rats.

Biased inverse agonism

The metabolite PF-6870961 shows enhanced potency at blocking β-arrestin recruitment compared to its parent drug, representing a distinct pharmacological profile at the ghrelin receptor.

What the researchers found

PF-6870961, the major hydroxy metabolite of the ghrelin receptor inverse agonist PF-5190457, demonstrated its own binding affinity and inverse agonist activity at GHSR1a. While it had lower binding affinity and potency for blocking inositol phosphate accumulation compared to the parent compound, it showed increased inhibitory potency at β-arrestin recruitment — a form of biased inverse agonism. Intraperitoneal injection suppressed food intake in both male and female rats under food-restricted and ad libitum conditions. Knockout experiments confirmed these effects were mediated specifically through the ghrelin receptor.

Why it matters

Understanding that a drug's metabolite is also pharmacologically active is critical for dosing, safety, and efficacy. The biased inverse agonism of PF-6870961 provides new structure-activity insights that could inform design of improved ghrelin receptor therapeutics for alcohol use disorder and potentially obesity.

How the study worked

The study combined high-throughput screening for off-target interactions, in vitro binding and concentration-response assays at GHSR1a, and in vivo food intake studies in male and female rats. GHSR knockout rats were used to confirm receptor specificity of the metabolite's effects.

What this study cannot tell us

All in vivo experiments were conducted in rats, and the metabolite's effects in humans remain to be characterized. The study focused on food intake as the behavioral readout rather than alcohol consumption, which is the primary clinical target. Pharmacokinetic properties of PF-6870961 in humans are not yet fully established.

How to read the evidence

This is a preclinical pharmacological characterization study combining in vitro assays with in vivo rat experiments and genetic knockout confirmation. It provides strong mechanistic evidence but lacks human clinical data.

When this study was published

Published in 2023, this study builds on a recent phase 1a clinical trial of the parent compound and addresses an active area of addiction therapeutics research.

The bigger picture

The ghrelin system has emerged as a promising therapeutic target for addiction and metabolic disorders. This study deepens our understanding of how drugs targeting this peptide hormone receptor work in the body, revealing that metabolites can have distinct pharmacological profiles that contribute to — and potentially complicate — therapeutic effects.

Questions still open

  • Does PF-6870961 contribute to the effects of PF-5190457 on alcohol consumption in humans?
  • Could the biased inverse agonism of PF-6870961 be exploited to design more selective ghrelin receptor therapeutics?
  • What are the relative plasma concentrations of the parent drug and metabolite in clinical dosing?

Common questions

What is the ghrelin receptor and why is it targeted for alcohol treatment?
The ghrelin receptor (GHSR1a) responds to ghrelin, the 'hunger hormone,' and plays a role in reward and appetite circuits in the brain. Blocking this receptor has shown promise in reducing alcohol craving and consumption in both preclinical and early clinical studies.
What does 'biased inverse agonism' mean?
An inverse agonist reduces the baseline activity of a receptor. 'Biased' means the drug preferentially blocks one signaling pathway over another — in this case, PF-6870961 is more potent at blocking β-arrestin recruitment than inositol phosphate signaling, which could produce different therapeutic effects than the parent drug.

Read the original research

Initial Pharmacological Characterization of a Major Hydroxy Metabolite of PF-5190457: Inverse Agonist Activity of PF-6870961 at the Ghrelin Receptor.

The Journal of pharmacology and experimental therapeutics, 386(2), 117-128

Citation

Deschaine, Sara L; Hedegaard, Morten A; Pince, Claire L; Farokhnia, Mehdi; Moose, Jacob E; Stock, Ingrid A; Adusumalli, Sravani; Akhlaghi, Fatemeh; Hougland, James L; Sulima, Agnieszka; Rice, Kenner C; Koob, George F; Vendruscolo, Leandro F; Holst, Birgitte; Leggio, Lorenzo. (2023). Initial Pharmacological Characterization of a Major Hydroxy Metabolite of PF-5190457: Inverse Agonist Activity of PF-6870961 at the Ghrelin Receptor.. The Journal of pharmacology and experimental therapeutics, 386(2), 117-128. https://doi.org/10.1124/jpet.122.001393