Novo Nordisk has initiated the ambitious REDEFINE and REIMAGINE phase 3 clinical programs to investigate the efficacy of combining cagrilintide and semaglutide (CagriSema) for weight management and type 2 diabetes (T2D) treatment across a range of patient populations.
The REDEFINE program is primarily focused on assessing the weight loss potential of cagrilintide + semaglutide in individuals with and without diabetes. This program consists of six trials, five of which have been detailed [13]:
REDEFINE 1: A 68-week trial involving 3,400 patients, comparing cagrilintide + semaglutide against monotherapies and placebo, with weight loss as the primary outcome.
REDEFINE 2: A 68-week trial with 1,200 patients, comparing cagrilintide + semaglutide against placebo, focusing on weight loss as the primary outcome.
REDEFINE 3: A large-scale trial involving 7,000 patients, assessing cagrilintide + semaglutide with a focus on 3-point major adverse cardiovascular events as the primary outcome.
REDEFINE 4: A 72-week head-to-head trial involving 800 patients, comparing cagrilintide + semaglutide against tirzepatide, with weight loss as the primary outcome.
REDEFINE 5: A 68-week trial conducted in East Asia with 330 patients, comparing cagrilintide + semaglutide against semaglutide 2.4 mg, with weight loss as the primary outcome.
In parallel, Novo Nordisk's REIMAGINE program is specifically targeting the management of T2D through the combined use of cagrilintide and semaglutide. This program encompasses four trials [14, 15, 16]:
REIMAGINE 1: A 40-week trial involving 180 patients with T2D, comparing cagrilintide + semaglutide against placebo, with HbA1c as the primary outcome.
REIMAGINE 2: A 68-week trial with 2,700 patients on metformin (MET) with or without SGLT-2 inhibitors, comparing cagrilintide + semaglutide against semaglutide, cagrilintide, and placebo, with both HbA1c and body weight as primary outcomes.
REIMAGINE 3: A 40-week trial involving 270 patients with T2D on basal insulin with or without MET, assessing cagrilintide + semaglutide as an add-on therapy compared to placebo, with HbA1c as the primary outcome.
REIMAGINE 4: A 68-week head-to-head trial with 1,000 patients on MET with or without SGLT-2 inhibitors, comparing cagrilintide + semaglutide against tirzepatide, focusing on HbA1c and body weight as primary outcomes.
These comprehensive and large-scale studies aim to establish cagrilintide + semaglutide efficacy and safety profile, potentially positioning it as a key therapeutic option for both weight management and diabetes control.
All of these trials are in the recruitment phase, and the first results are expected as soon as 2026-2027.