Clinical Trials

//Clinical Trials
Clinical Trials2019-03-01T14:08:38-05:00

Clinical Trials

Achieve is advancing the clinical development of cytisinicline in the United States and recently completed enrollment in the Phase 2b ORCA-1 trial. Press release: Achieve Life Sciences Announces Completion of Enrollment in 254-Subject Phase 2b Trial of Cytisinicline for Smoking Cessation.

ORCA Program


This Phase 2b trial is being conducted in the US to assess various dosing schedules of cytisinicline in approximately 250 people. It will evaluate efficacy based on the overall reduction in the number of cigarettes smoked during the various study treatment doses and schedules. It will also compare compliance and safety profiles, compared to the respective placebo arms. Results from this study will be used for defining future cytisinicline development.

Study Design

This is a six-arm, multi-center, double-blind, randomized, placebo-controlled, Phase 2b study conducted in the US. The study is double-blinded to dose but not to the administration schedule. Subjects must provide a quit date 5-7 days from randomization. Study treatment must start the day after randomization such that study treatment is initiated prior to the quit date.

Subjects must meet all inclusion and exclusion criteria. Subjects will be stratified at randomization by BMI class (18.5 to <25 kg/m2; 25 to <30 kg/m2; 30 to <35 kg/m2). A total of approximately 250 subjects will be randomized 2:2:1:2:2:1 in a blinded manner to either Arm A or Arm B, vs Arm C or Arm D or Arm E vs Arm F.

ORCA-1 Study Design

ORCA-1 Program Study Design. Click image to enlarge.

ORCA-1 Trial Locations

ORCA-1 is being conducted at the following states in the US.

ORCA-1 Trial Locations

To learn more about the ORCA-1 trial, please visit www.OrcaProgram.com

Phase 3 trials

It is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction, including approximately 2,000 patients in Phase 3 clinical trials conducted in Europe and New Zealand and published in the New England Journal of Medicine. The United States cytisinicline Phase 3 development program is expected to initiate in late-2019.