Novo Nordisk Accelerates Global Phase III Program for CagriSema with 10 Trials Launched, Challenging Lilly’s Retatrutide
Novo Nordisk
Insulin Developer and Manufacturer
On June 5, according to the CDE Clinical Trial Registration and Information Disclosure Platform, Novo Nordisk's semaglutide compound preparation...CagriSema Phase III Clinical Trial Initiated in ChinaBedREIMAGINE 3 Study,To evaluate the efficacy and safety of once-weekly subcutaneous injection of CagriSema compared with placebo in patients with type 2 diabetes receiving once-daily basal insulin with or without metformin.(Registration No.：CTR20241846）。
Source: CDE Official Website
The study was registered and initiated on ClinicalTrials.gov in March this year (Registration No.:NCT06323161）, and on March 26, the enrollment of the world's first subject was completed.This launch is for the part in China.
CagriSema isA compound drug consisting of Semaglutide and a long-acting Amylin analog, Cagrilintide.According to the Insight database,CagriSema was first filed for clinical trials in China in June 2022, received its first clinical approval in August of the same year, and initiated its first clinical trial in July of the previous year.
For type 2 diabetes, a Phase III trial has been initiated in China last year.REIMAGINE 2 Study (Registration Number:CTR20240080), EvaluationCagriSema vs Semaglutide inEfficacy in patients with type 2 diabetes treated with metformin (with or without SGLT2 inhibitors), the first participant was enrolled in March this year.
Previously, Novo Nordisk had completed a Phase II clinical trial in the United States for the treatment of type 2 diabetes (Registration Number:NCT04982575), the disclosed data results indicate that CagriSema demonstrates superior blood sugar reduction and weight loss effects compared to semaglutide.CagriSema group participants achieved an average HbA1c reduction of -2.18% from baseline, with an average weight loss of 15.6%, significantly outperforming semaglutide monotherapy's -1.79% and -5.1%.
Source: Official website of Novo Nordisk (Unless otherwise specified, the following content is from the same source)
Globally, according to the Insight database,CagriSema has globally registered and initiated 10 Phase III clinical trials, including 3 for glycemic control and 7 Items for Weight Loss。
In the field of blood sugar reduction，In addition to the two global clinical trials mentioned above, it also includes one that was initiated in January this year.Head-to-Head TirzepatidePhase III Clinical Trial (Registration Number:NCT06221969), planning to enroll 1,000 participants, with the primary endpoint expected to be reached by November next year.
Global Launch of CagriSema Phase III Clinical Trial for Type 2 Diabetes
Source: Insight Database Web Version
In the field of weight loss, includingREDEFINE 1～6 Six studies and a Phase III clinical trial recently registered in April this year, conducted in regions such as the United States, France, and Germany, with the first participant expected to be enrolled on June 24.
REDEFINE 1-5 Study details are shown in the figure below,REDEFINE 6 Study isOneComparison of Semaglutide inChinese overweight or obese subjectsEvaluate Efficacy and SafetyPhase III Clinical Trial (Registration Number: CTR20232030/NCT05996848), the enrollment of the first subject was completed in August last year, and the primary endpoint is expected to be reached by February next year.
In addition, Novo Nordisk plans to explore the therapeutic potential in more metabolic disease areas, including OSA, and has currently initiated respectivelyTargetingMASH and CKDIPhase I ClinicalResearch。
The GLP-1 field has long been dominated by a duel between Novo Nordisk and Eli Lilly.The former has liraglutide and the star drug semaglutide,The latter has dulaglutide and a new generation dual-target drug, tirzepatide.The future successors are also "vying for the lead."Novo Nordisk's CagriSema, a compound of semaglutide, andLilly'sGLP1R/GCGR/GIPR Tri-target AgonistRetatrutide, the latterCurrently, 8 Phase III clinical trials have been launched globally.For more details, see previous articles from Insight >>>Lilly Launches 8 Phase III Clinical Trials with Three Agonist Retatrutide Accelerating to Market
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