What question did this study set out to answer?

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel once-weekly glucagon/GLP-1 receptor co-agonist NNC9204-1177 in adults with overweight or obesity.

September 9, 2023Molecular MetabolismOpen Access

Results from three phase 1 trials of NNC9204-1177, a glucagon/GLP-1 receptor co-agonist: Effects on weight loss and safety in adults with overweight or obesity

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Authors

MFMartin FriedrichsenNovo Nordisk (Denmark)LELars EndahlNovo Nordisk (Denmark)FKFrederik Flindt KreinerNovo Nordisk (Denmark)

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Implication

Randomized double-blind trials reveal substantial weight loss alongside unexpected toxicity with NNC9204-1177 in adults with obesity, indicating safety signals preclude its clinical development.

Key Points

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel once-weekly glucagon/GLP-1 receptor co-agonist NNC9204-1177 in adults with overweight or obesity.
Evaluated findings across three phase 1 studies, focused on a 12-week, multiple ascending dose (MAD), double-blind, placebo-controlled trial (N=99) testing doses from 200 to 6000 μg.
Included a single ascending dose, double-blind, placebo-controlled trial (N=49; doses 10 to 1100 μg) and an open-label drug-drug interaction trial (N=45; 4200 μg).
NNC9204-1177 demonstrated a steady-state geometric mean half-life of 77 to 111 hours and produced dose-dependent weight loss reaching up to 12.6% at week 12 with the 4200-μg dose in the MAD trial.
Treatment triggered unexpected safety signals, including elevated heart rate, reduced reticulocyte count, decreased blood amino acids, and impaired glucose tolerance.
Safety assessments also revealed increased inflammatory markers (fibrinogen and C-reactive protein) and elevated liver transaminases (AST and ALT), prompting discontinuation of development.

Cite This Study

Friedrichsen et al. (2023) studied this question.

synapsesocial.com/papers/6a75b4f41eaff9cba91613aa https://doi.org/10.1016/j.molmet.2023.101801

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Implication

Randomized double-blind trials reveal substantial weight loss alongside unexpected toxicity with NNC9204-1177 in adults with obesity, indicating safety signals preclude its clinical development.

Results from three phase 1 trials of NNC9204-1177, a glucagon/GLP-1 receptor co-agonist: Effects on weight loss and safety in adults with overweight or obesity

Discussion

Member takes

Implication

Key Points

Cite This Study

Results from three phase 1 trials of NNC9204-1177, a glucagon/GLP-1 receptor co-agonist: Effects on weight loss and safety in adults with overweight or obesity

Discussion

Member takes

Implication

Key Points

Cite This Study

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