Randomization, study medication, and standard of care
Participants were 1:1 randomized according to a computer-generated randomization list (randomly selected, varying block sizes; no stratification). Participants received a once-weekly, subcutaneous injection of either dulaglutide or placebo. Dulaglutide was injected at an initial dose of 0.75 mg/0.5 mL in the first week and then increased to 1.5 mg/0.5 mL in the following weeks until the end of treatment. The placebo intervention was a 0.5 mL injection of 0.9% NaCl. The standard of care included behavioral counselling according to individual needs and a 12-week treatment with the nicotinic receptor partial agonist varenicline, which was uptitrated to a daily dose of 2 mg.