Novo Nordisk Advances Cagrilintide to Phase 3 Clinical Program After Positive Results

Trial Results

Novo Nordisk's phase 3 REDEFINE 1 trial showed that cagrilintide, a long-acting amylin analogue, resulted in an average weight loss of 11.8% compared to 2.3% with placebo after 68 weeks. Approximately 31.6% of participants achieved a weight loss of 15% or more with cagrilintide, compared to 4.7% with placebo.

Tolerability

Cagrilintide was generally well-tolerated, with gastrointestinal side effects such as nausea, vomiting, diarrhea, and constipation being the most common. These side effects were mostly mild to moderate and transient. Nausea led to discontinuation in 1.0% of cagrilintide participants, compared to 0.1% for placebo.

Future Plans

Based on these results, Novo Nordisk plans to advance cagrilintide into the RENEW phase 3 clinical program, set to begin in Q4 2025. This program will further investigate the efficacy and safety of cagrilintide in individuals with obesity or overweight.

Study Details

The REDEFINE 1 trial was a double-blind, placebo-controlled study involving 3,417 adults with obesity or overweight and related comorbidities, excluding type 2 diabetes. It evaluated the efficacy and safety of cagrilintide 2.4 mg monotherapy over 68 weeks.