Phase 1a: First-in-Human Single Ascending Dose Study (NCT02951806) Study Title: "Safety, Tolerability, and Pharmacokinetics of Single Doses of Cagrilintide in Healthy Subjects" Status: Completed Phase: Phase 1a Enrollment: 48 healthy volunteers Study Period: 2016-2017 Location: Single center (Denmark) Design: Randomized, double-blind, placebo-controlled, single ascending dose Dose Range: 0.03-10 mg SC Primary Endpoints: Safety, tolerability, PK parameters Population: Healthy male subjects, BMI 20-28 Key Results: Pharmacokinetics: Terminal half-life 5-7 days across dose range
In some embodiments, triglycerides comprising medium chain fatty acids are coconut oil, cohune oil, palm kernel oil, tucum oil, or any combinations thereof
Gradual titration is incorporated into trial protocols to improve gastrointestinal tolerability, as nausea and vomiting are most common during early treatment phases or rapid dose escalation [2]
Moreover, researchers investigate the compounds effects on muscle function and overall energy use
The most common side effects were: Nausea Vomiting Diarrhea Constipation Fatigue Abdominal discomfort Early satiety Injection site reactions Increased heart rate in the first 24 weeks, but that returned to normal after 24 weeks
doi: 10.3727/096368913X667709