ALN-KHK / Alnylam - LARVOL DELTA

A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM (clinicaltrials.gov) - P1/2 | N=49 | Terminated | Sponsor: Alnylam Pharmaceuticals | Active, not recruiting ➔ Terminated; Business reasons (not safety related)

Trial termination • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Alnylam Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=160 ➔ 49 | Trial completion date: Dec 2025 ➔ Apr 2025 | Trial primary completion date: Dec 2025 ➔ Apr 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Alnylam Pharmaceuticals | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

ALN-KHK, an Investigational RNA Interference Therapeutic, Successfully Targets Hepatic Ketohexokinase in a Single Ascending Dose Study of Overweight to Obese Adults (ADA 2024) - P1/2 | "Interim results of this first clinical study of ALN-KHK demonstrate an encouraging safety and tolerability profile with target engagement in overweight to obese adults, supporting its further evaluation in patients with type 2 diabetes."

Clinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • FGF21

A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Alnylam Pharmaceuticals

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Preclinical Development of ALN-KHK, an Investigational RNAi Therapeutic for Type 2 Diabetes Mellitus (ADA 2023) - "These data suggest monitoring of circulating fructose and FGF21 to assess KHK silencing in the clinic. In IND-enabling rat and non-human primate toxicology studies ALN-KHK was safe and well tolerated, supporting the planned initiation of first-in-human studies in obese healthy volunteers."

Preclinical • Diabetes • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Obesity • Type 2 Diabetes Mellitus • FGF21

A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Alnylam Pharmaceuticals

New P1/2 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • FGF21