First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Phase 1 Completed 56 enrolled Novo Nordisk A/S

RandomizedSingle-groupDouble-blindTreatment

Summary

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.

Timeline

Start: 2017-01-06
Primary completion: 2017-10-26
Completion: 2017-10-26

Publications

Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	zalfermin	Protein / enzyme biologic	2 mg	Subcutaneous
Subject	zalfermin	Protein / enzyme biologic	6 mg	Subcutaneous
Subject	zalfermin	Protein / enzyme biologic	12 mg	Subcutaneous
Subject	zalfermin	Protein / enzyme biologic	24 mg	Subcutaneous
Subject	zalfermin	Protein / enzyme biologic	48 mg	Subcutaneous
Subject	zalfermin	Protein / enzyme biologic	96 mg	Subcutaneous
Subject	zalfermin	Protein / enzyme biologic	180 mg	Subcutaneous

First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Summary

Timeline

Publications

Drugs

Indications