zalfermin (NNC0194-0499) / Novo Nordisk - LARVOL DELTA

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=698 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Rational Design of Site-Specific Fatty Acid Derivatives to Extend the Half-Life of Fibroblast Growth Factor 21. (PubMed, Bioconjug Chem) - "Furthermore, these analogues showed superior biological activity in the presence of albumin, outperforming the C-terminal-derived variant zalfermin. This rational design approach not only improves the pharmacokinetic profile of FGF21 but also provides a framework for enhancing the therapeutic potential of other small proteins."

Journal • Metabolic Disorders • FGF21

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Hepatology

A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children. (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion • Trial primary completion date • Hepatology • Long-acting Reversible Contraceptives • Metabolic Dysfunction-Associated Steatohepatitis

Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Jun 2025 ➔ Nov 2025

Combination therapy • Trial completion date • Trial primary completion date • Hepatology

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Aug 2024 ➔ Jan 2025 | Trial primary completion date: Aug 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Hepatology

Development of Zalfermin, a Long-Acting Proteolytically Stabilized FGF21 Analog. (PubMed, J Med Chem) - "Here, we describe the development of the FGF21 analog zalfermin (NNC0194-0499, 15), intended for once-weekly sc dosing...The fatty diacid binds albumin in a reversible manner, such that the free fraction of zalfermin potently activates the FGF-receptor complex and retains receptor selectivity compared with FGF21, providing strong efficacy on body weight loss in diet-induced obese mice. Zalfermin is currently being clinically evaluated for the treatment of metabolic dysfunction-associated steatohepatitis."

Journal • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • FGF21

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=672 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Trial primary completion date: May 2024 ➔ Oct 2024

Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hepatology

Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Novo Nordisk A/S

Combination therapy • New P2 trial • Hepatology

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Apr 2024 ➔ Aug 2024 | Trial primary completion date: Apr 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Hepatology

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations (clinicaltrials.gov) - P1 | N=53 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children. (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hepatology • Long-acting Reversible Contraceptives • Metabolic Dysfunction-Associated Steatohepatitis

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Nov 2023 ➔ Feb 2024 | Trial primary completion date: Nov 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=672 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Non-alcoholic Steatohepatitis

A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Nov 2023 | Trial primary completion date: Feb 2024 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis • Renal Disease

A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Non-alcoholic Steatohepatitis • Renal Disease

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Jun 2023

Trial completion • Trial completion date • Hepatology • Non-alcoholic Fatty Liver Disease

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function (clinicaltrials.gov) - P1 | N=35 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hepatology

A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Non-alcoholic Fatty Liver Disease

A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Non-alcoholic Steatohepatitis • Renal Disease

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Non-alcoholic Steatohepatitis

A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hepatology • Non-alcoholic Steatohepatitis

A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hepatology • Non-alcoholic Fatty Liver Disease