Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Start Date10 Feb 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT06797869

/ RecruitingPhase 2

Efficacy and Safety of co Administered Cagrilintide and Semaglutide (CagriSema) Once Weekly Versus Placebo in Participants With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.

Start Date29 Jan 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT06716307

/ RecruitingPhase 1

Comparing the Pharmacokinetics of Cagrilintide and Semaglutide Following Single Subcutaneous Doses of Different CagriSema Presentations, in a Crossover Manner in Adult Participants With Overweight or Obesity

This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.

Start Date02 Dec 2024

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with CagriSema

100 Translational Medicine associated with CagriSema

100 Patents (Medical) associated with CagriSema

629

Literatures (Medical) associated with CagriSema

01 Jan 2025·Pharmacological Reviews

Emerging pharmacotherapies for obesity: A systematic review

Article

Author: Kokkorakis, Michail ; Valenzuela-Vallejo, Laura ; Chakhtoura, Marlene ; Al Rifai, Jana ; Rhayem, Caline ; Mantzoros, Christos S. ; Mantzoros, Christos S ; Ghezzawi, Malak

The history of anti-obesity pharmacotherapies is marked by disappointments, often entangled with societal pressure promoting weight loss and the conviction that excess body weight signifies a lack of willpower. However, categories of emerging pharmacotherapies generate hope to reduce obesity rates. This systematic review of phase 2 and phase 3 trials in adults with overweight/obesity investigates the effect of novel weight loss pharmacotherapies, compared to placebo/control or Food and Drug Administration-approved weight loss medication, through searching Medline, Embase, and ClinicalTrials.gov (2012-2024). We identified 53 phase 3 and phase 2 trials, with 36 emerging anti-obesity drugs or combinations thereof and four withdrawn or terminated trials. Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide, survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate. Completed phase 2 trials on incretin-based therapies showed a mean percent weight loss of 7.4-24.2%. Almost half of the drugs undergoing phase 2 trials were incretin analogs. The obesity drug pipeline is expanding rapidly, with the most promising results reported with incretin analogs. Data on mortality and obesity-related complications, such as cardio-renal-metabolic events, are needed. Moreover, long-term follow-up data on the safety and efficacy of weight maintenance with novel obesity pharmacotherapies, along with studies focused on under-represented populations, cost-effectiveness assessments, and drug availability, are needed to bridge the care gap for patients with obesity. Significance Statement Obesity is the epidemic of the 21st century. Except for the newer injectable medications, drugs with suboptimal efficacy have been available in the clinician's armamentarium. However, emerging alternatives of novel agents and combinations populate the obesity therapeutic pipeline. This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives.

01 Oct 2024·Current Diabetes Reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity

Review

Author: Aliter, Kholoud F. ; Al-Horani, Rami A. ; Aliter, Hashem F.

Abstract:Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity

01 Sep 2024·Indian Journal of Endocrinology and Metabolism

Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis

Review

Author: Hathur, Basavanagowdappa ; Dutta, Deep ; Nagendra, Lakshmi ; Harish, BG ; Joshi, Ameya ; Sharma, Meha ; Kamrul-Hasan, ABM

AbstractNo meta-analysis has analysed role of cagrilintide as weight-loss medication in obese individuals. Electronic databases were searched for RCTs involving obese individuals receiving cagrilintide or cagrilintide-2.4 mg with semaglutide-2.4 mg combination (Cagrisema) compared to placebo/active comparator. Primary outcomes were changes in body weight; secondary outcomes were alterations in glycemia, lipids, and adverse events. From 678 articles, data from 3 RCTs involving 430 individuals were analysed. At 20–32 weeks, patients receiving Cagrisema weekly had significantly greater percentage [mean difference (MD)−9.07% (95%CI: −11.91, −6.23); P < 0.00001;I2 = 96%] and absolute [MD-9.11 kg (95%CI: −12.84, −5.39); P < 0.00001; I2 = 98%] weight-loss, compared to semaglutide 2.4 mg weekly. At 26–32 weeks, cagrilintide 2.4 mg had a similar percentage [MD − 1.83% (95%CI: −4.08, −0.42); P = 0.11; I2 = 98%] and absolute [MD − 1.88 kg (95%CI: −4.23,0.47); P = 0.12; I2 = 98%] weight-loss, compared to semaglutide/liraglutide. Treatment-emergent and serious adverse events were comparable between groups. Gastrointestinal adverse events and vomiting were significantly higher with Cagrisema compared to semaglutide. Vomiting was significantly lower with cagrilintide compared to semaglutide/liraglutide. Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.

News (Medical) associated with CagriSema

12 Mar 2025

·endpts.com

Updated: Zealand partners with Roche on its amylin analog in a deal worth up to $5.3B

Zealand Pharma has finally found a partner. And according to the Danish company, the licensing deal it announced with Roche on Wednesday for its amylin analog petrelintide is the biggest ever for an obesity candidate to date. The companies said the Swiss pharma is paying Zealand $1.65 billion upfront in cash. $1.4 billion of that will be given once the deal is closed, which is expected to be in the second quarter of this year, and $250 million over the next two years every time the partnership celebrates an anniversary. Importantly, Roche and Zealand will also investigate petrelintide combinations. The first on the list for co-administration is Roche’s GLP-1/GIP agonist candidate CT-388, which Roche obtained from its acquisition of Carmot Therapeutics in late 2023. CT-388 has shown effectiveness in early trials but had high rates of gastrointestinal side effects; combining it with amylin could allow a more potent weight loss effect, allowing lower, safer doses. The ghost at the feast is Novo Nordisk’s amylin-incretin combo CagriSema, which has disappointed in late-stage trials in patients with obesity and with obesity and diabetes . CEO Adam Steensberg told Endpoints News in an interview that Zealand can do better. CagriSema combines equal 2.4 mg doses of Novo’s amylin analog cagrilintide and GLP-1 semaglutide, and Steensberg suggests this ratio is “suboptimal.” “We think you need to max out on amylin … then just add a little bit of GLP-1/GIP on top,” he said. In Zealand’s ongoing Phase 2b monotherapy trial in obese patients, petrelintide is being dosed at up to 9 mg . Data from this trial are due by mid-2026. Steensberg said that having Roche on board as a partner does not alter its plans for Phase 3 trials of petrelintide, but could accelerate them. “We look very much forward to also having their input into the details of the program,” he said. “The key focus will be on obesity as a first indication, with an ambition of rapidly expanding into additional indications,” Steensberg said. These are yet to be confirmed, but he did not rule out research in diabetes and the liver disorder MASH. Zealand believes that petrelintide monotherapy and the incretin combo will eventually be used to treat different populations. The former “will be a product for the majority of obese individuals,” Steensberg said, whereas “the most morbidly obese patients, they could benefit from a combination therapy.” The combo could also be of use in patients with both obesity and type 2 diabetes. On Zealand’s side, the collaboration is strictly on petrelintide — its other obesity candidates, such as the GLP-1/GLP-2 drug dapiglutide, are not involved. But other injected Roche assets might be used in future combinations, Steensberg said. Roche’s weight loss portfolio mainly stems from its $2.7 billion acquisition of Carmot. Roche has another GLP-1/GIP agonist, CT-868, and one of the brightest oral obesity hopes, a pill called CT-996. The company also has an anti-latent myostatin product called GYM329. Including milestone payments, the companies estimate the deal to be worth up to $5.3 billion. As part of the deal, Zealand will pay Roche $350 million for its share in studying CT-388 as a combo with petrelintide. The companies said they will split revenues — and losses — on their first monotherapy and combo drugs on a “50/50 basis” in the US and Europe. Steensberg described the profit share as the “true value” of the deal. Zealand could get royalties on net sales in other countries. Another major aspect of this deal is Roche’s manufacturing network and commercial reach. With the leading weight loss drug companies Eli Lilly and Novo Nordisk having to find ways to scale up manufacturing quickly, others yet to enter the market are mapping out commercial production plans much earlier in the process. Zealand has not been shy in declaring it was looking for a partner to study and commercialize its lead weight loss candidate. It has been on the hunt for a year or so now, and three weeks ago Steensberg told Endpoints the biotech was “exactly where we want to be.” Zealand is up 35% on the Danish stock exchange. Additional reporting by Reynald Castaneda. Editor’s note: This article has been updated throughout after an interview with Zealand CEO Adam Steensberg and stock reaction.

Phase 2License out/inAcquisition

11 Mar 2025

·www.echemi.com

Novo Nordisk's Next-Gen Diabetes Drug Shows 15.7% Weight Loss Yet Shares Plummet

Novo Nordisk's latest trial results for its next-generation diabetes drug, CagriSema, have revealed a 15.7% weight loss in overweight or obese patients with type 2 diabetes after 68 weeks of treatment. However, despite these promising findings, the company's shares fell by 5% following the announcement, indicating investor disappointment over the results. The trial, known as REDEFINE 2, involved around 1,200 participants and aimed to assess whether CagriSema could outperform Novo's existing blockbuster medications, Ozempic and Wegovy. The drop in share price reflects concerns that the weight loss achieved was lower than anticipated, especially after another disappointing trial for CagriSema earlier in December. CagriSema is a weekly injection that combines semaglutide—the active ingredient in Wegovy—with a molecule called cagrilintide, which mimics the pancreatic hormone amylin. This combination works to suppress hunger and regulate blood glucose levels. Notably, 61.9% of the trial participants were on the highest dose after the treatment period. While the weight loss results are significant, the market's reaction underscores the high expectations set for this innovative treatment. As the competitive landscape in diabetes and obesity medications continues to evolve, Novo Nordisk faces challenges in maintaining investor confidence amidst fluctuating trial outcomes.

10 Mar 2025

·pipelinereview.com

CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial

BAGSVAERD, Denmark I March 10, 2025 I Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight of 102 kg. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo. The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose. When evaluating the effects of treatment, if all people adhered to treatment 1 , people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo. When applying the treatment policy estimand 2 , people treated with CagriSema achieved a superior weight loss of 13.7% compared to 3.4% with placebo. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class. “The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes”, said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.” Novo Nordisk expects to file for the first regulatory approval of CagriSema in the first quarter of 2026. The detailed results from REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025. About CagriSema Once-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake. About the REDEFINE clinical trial programme REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. The global clinical trial programme consists of two pivotal phase 3 trials, which have enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes: REDEFINE 1 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight. REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes. REDEFINE 4 – an 84-week efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide 15 mg in 800 adults with obesity. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook , Instagram , X , LinkedIn and YouTube . 1 Based on the trial product estimand according to the trial protocol, regardless of dose strength 2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence SOURCE: Novo Nordisk

Phase 3Clinical ResultPhase 2

100 Deals associated with CagriSema

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	United States	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Japan	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Austria	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Germany	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Thailand	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Canada	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Ireland	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Hungary	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Malaysia	Novo Nordisk A/S	01 Feb 2023
Obesity	Phase 3	Poland	Novo Nordisk A/S	01 Feb 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05394519 (REDEFINE 2, NEWS 1 \| NEWS 2) Manual	Phase 3	Overweight \| Obesity	-	CagriSema	(tumlkccwfr) = deojedjnyg msdofjiuel (jzdkcfhghj ) View more	Negative	10 Mar 2025
				Placebo	(tumlkccwfr) = rlgrsgohjw msdofjiuel (jzdkcfhghj ) View more
EASD2023	Not Applicable	-	-	CagriSema	kzuwlcliys(lrgxteomvt) = pfcssvkroj bmsoizlzau (inxvekprqr ) View more	Positive	03 Oct 2023
				Cagrisema (Weight matched group (WM))	kzuwlcliys(lrgxteomvt) = retkwktyyv bmsoizlzau (inxvekprqr )
NAASO2022	Not Applicable	-	-	Vehicle control	ppkqxrqvww(dwfobkfhtr) = bjvovtysau ndpdzxsfxk (txawvfawbt ) View more	-	21 Nov 2022
				CagriSema	ppkqxrqvww(dwfobkfhtr) = vknbjzzjtn ndpdzxsfxk (txawvfawbt ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis