Novo Nordisk Advances Semaglutide Combination Therapy for NASH with FGF21 Analog NNC0194-0499

On March 13, Novo Nordisk registered a Phase I clinical trial on the ClinicalTrials.gov website to evaluate the pharmacokinetics of the NNC0194-0499/semaglutide combination formulation in healthy subjects.

The study plans to enroll 48 subjects, comprising three cohorts in total:

① Once weekly subcutaneous injection of NNC0194-0499 (30mg, weeks 1-20) + semaglutide (0.24mg for weeks 1-4, 0.5mg for weeks 5-8, 1.0mg for weeks 9-12, 1.7mg for weeks 13-16, and 2.4mg for weeks 17-20). Patients will also receive a combination of NNC0194-0499/semaglutide (formulation: 40/3.2mg/mL, target dose: 30mg/2.4mg) during weeks 21-24.

②Once a month subcutaneous injection of NNC0194-0499/Semaglutide compound (specification: 40/3.2mg/mL, 3.1mg/0.25mg for weeks 1-4, 6.3mg/0.5mg for weeks 5-8, 12.5mg/1.0mg for weeks 9-12, 21.3mg/1.7mg for weeks 13-16, and 30mg/2.4mg for weeks 17-20);

③ Once a month, subcutaneous injection of NNC0194-0499/semaglutide compound (specification: 40/0.33 mg/mL, target dose: 30mg/0.25mg).

The study began on February 28, 2023, and is expected to be completed on November 8, 2023. (Click to read the original text for more details on the specific protocol of the study.)

Novo Nordisk is developing a combination therapy of NNC0194-0499 and semaglutide for the treatment of non-alcoholic steatohepatitis (NASH). NNC0194-0499, a fibroblast growth factor 21 (FGF21) analog developed by Novo Nordisk, is intended for the treatment of NASH and obesity. FGF21, a member of the FGF19 subfamily, is primarily expressed in the liver and regulates metabolism, including glucose and lipid balance. Currently, 13 FGF21-based drugs worldwide have entered clinical research, with six, including NNC0194-0499, now in Phase II clinical trials.

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