Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema 2.4mg or 2.4 mg) once weekly versus semaglutide 2.4 mg, cagrilintide 2.4 mg and placebo in people withchronic kidney disease and type 2 diabetes living with overweight or obesity - Nil

Start Date18 Nov 2024

Sponsor / Collaborator

Novo Nordisk India Pvt Ltd.

NCT06534411 / Not yet recruitingPhase 3

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Start Date05 Nov 2024

Sponsor / Collaborator

Novo Nordisk A/S

CTR20241846 / RecruitingPhase 3

2型糖尿病受试者在每日一次基础胰岛素伴或不伴二甲双胍的基础上加用cagrilintide和司美格鲁肽（CagriSema）2.4 mg/2.4 mg和1.0 mg/1.0 mg皮下每周一次复方制剂与安慰剂相比的有效性和安全性

[Translation] Efficacy and safety of cagrilintide and semaglutide (CagriSema) 2.4 mg/2.4 mg and 1.0 mg/1.0 mg subcutaneously once-weekly combination added to once-daily basal insulin with or without metformin compared with placebo in subjects with type 2 diabetes

本研究将观察CagriSema帮助2型糖尿病患者降低血糖和体重的效果。

[Translation]

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and weight.

Start Date08 Jul 2024

Sponsor / Collaborator

Novo Nordisk China Pharmaceuticals Co. Ltd.

[+1]

100 Clinical Results associated with CagriSema

100 Translational Medicine associated with CagriSema

100 Patents (Medical) associated with CagriSema

1,229

Literatures (Medical) associated with CagriSema

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 Jul 2024·Hepatology Research

Hepatitis B surface antigen glycan isomer is a predictor of the development of hepatocellular carcinoma during nucleoside/nucleotide analog therapy

Article

Author: Enomoto, Masaru ; Hagihara, Atsushi ; Yukawa‐Muto, Yoshimi ; Fujii, Hideki ; Kotani, Kohei ; Uchida‐Kobayashi, Sawako ; Kawada, Norifumi ; Kawamura, Etsushi ; Odagiri, Naoshi ; Kozuka, Ritsuzo ; Motoyama, Hiroyuki

AbstractAimA recombinant monoclonal antibody against the hepatitis B surface antigen glycan isomer (HBsAgGi) was newly developed using the O‐glycosylated PreS2 peptide in M‐HBsAg of hepatitis B virus (HBV) genotype C. However, the association between HBsAgGi and the development of hepatocellular carcinoma (HCC) during nucleoside/nucleotide analog (NA) therapy remains unknown.MethodsA total of 112 HBV genotype C‐infected patients who were treated with NA were included in this study. We assessed the association between HBV markers, including HBsAgGi and other conventional markers, and the development of HCC during NA therapy.ResultsTen patients developed HCC during the follow‐up period. Of the HBV markers, HBsAg (≤3.53 log IU/mL; p = 0.047), HBsAgGi/HBsAg ratio (≥1.10; p = 0.035), and HBV DNA (≤6.3 log copies/mL; p = 0.012) at baseline and HBsAg (≤3.19 log IU/mL; p = 0.033) and HBsAgGi/HBsAg ratio (≥1.09; p = 0.003) at 48 weeks after NA therapy were significantly associated with the development of HCC according to the log rank test. In contrast, no significant association was observed between HBsAgGi and the development of HCC. Multivariate analysis revealed that a platelet count at baseline ≤88 × 103/mm3 (p = 0.026; hazard ratio [HR], 10.577) and an HBsAgGi/HBsAg ratio at 48 weeks after NA therapy ≥1.09 (p = 0.040; HR, 10.099) were independently and significantly associated with the development of HCC.ConclusionsOur findings suggest that a combination of on‐treatment HBsAgGi and HBsAg predicts the development of HCC during NA therapy.

01 Jul 2024·Hepatology Research

Risk of hepatocellular carcinoma after curative treatment when switching from tenofovir disoproxil fumarate or entecavir to tenofovir alafenamide: A real‐world multicenter cohort study

Article

Author: Park, Jeayeon ; Shin, Hyunjae ; Song, Byeong Geun ; Lee, Yun Bin ; Lee, Jeong-Hoon ; Ko, Yunmi ; Hur, Moon Haeng ; Park, Youngsu ; Yu, Su Jong ; Kim, Seung Up ; Kim, Yoon Jun ; Cho, Eun Ju ; Sinn, Dong Hyun ; Yoon, Jung-Hwan

AbstractAimAntiviral treatment reduces the risk of developing hepatocellular carcinoma (HCC) in patients with chronic hepatitis B. However, there is a lack of high‐quality evidence regarding the preventive effects of tenofovir alafenamide (TAF) on HCC. We evaluated the impact of TAF use after curative treatment on HCC recurrence.MethodsPatients who underwent surgery or radiofrequency ablation as a curative treatment for HCC were selected. Those patients who continued antiviral treatment with nucleos(t)ide analogs (NAs; entecavir [ETV] or tenofovir disoproxil fumarate [TDF]) or switched to TAF were included. The primary outcome was HCC recurrence, and the time‐varying effect of NA use on HCC recurrence was analyzed using various statistical methods.ResultsAmong 2794 consecutive patients with chronic hepatitis B who received curative treatment for HCC, 199 subsequently switched from ETV or TDF to TAF. After a median of 3.0 years, 1303 patients (46.6%) experienced HCC recurrence. After propensity score matching (ratio 1:10), switching to TAF was not associated with an increased HCC recurrence (HR 1.00, 95% CI 0.68–1.47; p = 1.00) by time‐varying Cox analysis. Switching to TAF was not associated with HCC recurrence in subgroups of NA (HR 1.06, 95% CI 0.67–1.67; p = 0.81 for TDF, and HR 1.09, 95% CI 0.51–2.33; p = 0.82 for ETV). Kaplan–Meier analysis showed comparable HCC recurrence‐free survival between patients who switched to TAF and those who continued with their NA (p = 0.08). Time‐varying Cox analyses in various subgroups confirmed the primary findings.ConclusionsTAF is as effective as TDF and ETV in preventing HCC recurrence after curative treatment.

News (Medical) associated with CagriSema

18 Nov 2024

·healthcare-digital.com

Novo Nordisk's CagriSema Next Gen Weight-Loss Treatment

Novo Nordisk is the most valuable company in Europe Novo Nordisk's journey as Europe's most valuable pharmaceutical company has led it to pioneer the next generation of weight-loss treatments Pharma giant Novo Nordisk is working on its ‘next generation’ weight-loss drug, CagriSema, which it believes will pioneer GLP-1 treatments. Glucagon-like peptide-1 (GLP-1) is a hormone which plays a vital role in glucose metabolism and appetite regulation. For over a century, Danish pharma Novo Nordisk has been working to prevent and cure chronic diseases. Now, it is the most valuable company in Europe. Novo Nordisk’s treatments benefit millions of people who live with diabetes or obesity, as well as those with rare blood and endocrine diseases. The company also produces 50% of the world’s insulin supply, including over 600m insulin pens and an estimated 36m people use the company’s diabetes care products. Novo Nordisk faces investor scepticism amid weight loss pill challenges Investor confidence in Novo Nordisk's capacity to satisfy product demand has diminished, compounded by disappointing results from an experimental weight loss pill announced in September. As a result, Novo Nordisk's shares have lagged behind those of its primary competitor in the weight-loss sector, Eli Lilly . Novo Nordisk expects data on the drug CagriSema to prove that the drug reduces weight by 25% in just over a year. This in comparison to: 16% from Novo Nordisk’s Wegovy Up to 22.5% by Eli Lilly’s rival Mounjaro However, the results are also expected to show that CagriSema only works when administered alongside a patients’ healthy diet and adequate amounts of exercise and sleep. “CagriSema is really important for us. It’s a next-generation product and it has the potential to be best in class,” said CEO Lars Fruergaard Jørgensen. CagriSema targets obesity and diabetes CagriSema is a novel combination therapy that mixes: Semaglutide, the active component in Novo Nordisk's Ozempic and Wegovy Cagrilintide, an amylin-based compound. This weekly injectable medication combines the GLP-1 mimicking effects of semaglutide with the properties of the pancreatic hormone amylin. The development of CagriSema has broader implications for the pharmaceutical industry, as other companies are also working on amylin-based treatments. These drugs, like GLP-1 agonists, aim to decrease food intake and improve blood glucose regulation. If CagriSema is successful, it could increase confidence in other companies developing amylin-based therapies. For instance, Zealand Pharma, a Danish company working on an amylin-only drug, has seen its market value double this year due to growing enthusiasm for this drug class. Novo Nordisk is currently conducting clinical trials for CagriSema in both obesity and type-2 diabetes treatment. The company is also running a head-to-head trial comparing CagriSema with Eli Lilly's Mounjaro. These efforts are part of Novo Nordisk's unprecedented investment in research and development to maintain its competitive edge. Novo Nordisk CEO advocates for affordable healthcare Over his 33 years at the company CEO Lars Fruergaard Jørgensen , leads the company through its various scientific breakthroughs, expanding access to medicine and working to cure diseases. Lars was invited to represent Novo Nordisk at a Senate hearing in the US, where he explained the pricing differences between medicine for sale in the US compared to other locations. Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk “I reaffirmed our focus on providing innovation, support and care for the people we serve,” he said. “Importantly, I also expressed my frustration that even though we're working hard to make our treatments more affordable, patients aren't seeing the reduction in prices, all too often.” Lars amplified the need for real change and practical solutions for people living with chronic and misunderstood diseases, such as diabetes and obesity. Make sure you check out the latest industry news and insights at Healthcare Digital and also sign up to our global conference series - Healthcare LIVE 2025 Healthcare Digital is a BizClik brand

13 Nov 2024

·endpts.com

Danish biotech Gubra touts early weight loss data in hot amylin field

The amylin field is heating up ahead of Novo Nordisk’s much-anticipated CagriSema readout later this year. On Wednesday, Gubra said people taking high doses of its amylin analog, called GUBamy, had a mean loss of 3% of their body weight in a six-week single ascending dose trial. The placebo group, meanwhile, experienced a mean gain of about 1% body weight, the Danish biotech said. Men who were “healthy lean and overweight” were included in the trial. Nausea and reduced appetite were frequent, and vomiting was “occasional” in the trial, Gubra said. Gastrointestinal side effects have been commonly reported with anti-obesity medicines. The news comes the same day obesity biotech Metsera raised $215 million and said it had started testing its own amylin analog in an early-stage clinical study. “I’m excited about these data. It’s confirming what we hoped for that GUBamy is well-tolerated and we were able to dose to quite high levels, and we saw some dose dependency in adverse events,” which is “exactly what you would expect from an amylin,” Gubra CEO Henrik Blou said in an interview with Endpoints News . Gubra’s shares were up about 2%. The company said it plans to share interim results from a multiple ascending dose study in the first half of next year. The biotech believes GUBamy, or GUB014295, can be dosed weekly given its 11 day half-life. Blou declined to disclose Gubra’s expectations for weight loss in the MAD Phase 1b trial. Zealand Pharma’s amylin analog petrelintide led to a mean 8.6% weight loss in a MAD study in June , and the company quickly raised $1 billion off that data. Asked if Gubra also plans to raise money or do a follow-on offering on the back of these data, Blou said Gubra has “no current plans” since the company is “currently well-financed.” Gubra can take GUBamy into Phase 2a, the CEO said, but the company is also exploring partnerships. It counts Boehringer Ingelheim as a partner on other obesity programs. There are likely multiple parties circling the company as amylin has come to the fore as a next-generation approach in the obesity drug landscape. Amylin and other approaches follow the first-generation GLP-1 medicines, which have opened up what is expected to be the biggest pharmaceutical market in history. Novo’s CagriSema, which combines an amylin analog with Wegovy, is slated to have a Phase 3 readout before 2025. Zealand, meanwhile, boasted at the ObesityWeek conference that it believes amylin could potentially replace GLP-1s for some patients. Eli Lilly, AstraZeneca, Structure Therapeutics and others are also in the race. GUBamy is one of multiple shots on goal for Gubra’s obesity pipeline. Its partner Boehringer started testing a triple agonist, of unknown mechanisms, in a Phase 1 this summer. However, Boehringer ended work on a different Gubra obesity drug last month. The duo is also working on other discovery-stage programs, and Gubra is working on its own with other targets, like UCN2 and GLP-1. Blou said Gubra is “still gathering information” on the culled Boehringer drug, a neuropeptide Y receptor type 2 (NPY2) agonist known as BI 1820237. Once it gets the “full picture,” they’ll have a better idea of the drug’s future, he added.

Phase 1Clinical ResultPhase 2Phase 3

13 Nov 2024

·firstwordpharma.com

Danish biotech Gubra touts early win for long-acting amylin in obesity

Two weeks after Boehringer Ingelheim pulled the plug on a partnered obesity programme, Gubra is reporting "positive" Phase I data for its long-acting amylin analogue GUBamy (GUB014295), indicating that the Danish biotech's independent assets may offer promising alternatives.In the single ascending dose study, subjects receiving the highest doses (3.5-6.0 mg) achieved approximately 3% weight reduction over six weeks, while the placebo group gained about 1%. The study was conducted in healthy lean and overweight male subjects with a mean body mass index (BMI) of about 26.7 who were randomised into six cohorts treated with either GUBamy or placebo."We are very pleased to see that our data confirms the potential of GUBamy as an anti-obesity treatment," said CEO Henrik Blou. "GUBamy was well tolerated, and the very long half-life supports a weekly dosing regimen."Gubra said the treatment's pharmacokinetic profile revealed a half-life of 270 hours, or 11 days, supporting weekly subcutaneous administration. Adverse events aligned with expectations for the drug class, primarily presenting as gastrointestinal effects including frequent nausea and reduced appetite, with occasional vomiting.Investors are paying close attention to trial outcomes of amylin-based drugs, which could soon represent a new category in weight-loss therapies. Before the end of the year, Novo Nordisk plans to release data from a large study of CagriSema, a combination of the dual amylin and calcitonin receptor agonist cagrilintide, plus GLP-1 agonist semaglutide, the active ingredient in its popular obesity drug Wegovy. The drugmaker recently reiterated its expectation that the new injection will deliver 25% weight loss.Meanwhile, Zealand Pharma has its own amylin compound, petrelintide, and is actively seeking partners to advance the treatment to the next development phases.

Clinical ResultPhase 1

100 Deals associated with CagriSema

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	CZ	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	SI	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	HR	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	FI	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	MX	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	BG	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	CO	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Diabetes Mellitus, Type 2	Phase 3	DK	Novo Nordisk Pharmaceuticals Pty Ltd.	27 Sep 2023
Obesity	Phase 3	CN	Novo Nordisk China Pharmaceuticals Co. Ltd.	15 Aug 2023
Obesity	Phase 3	CN	Novo Nordisk Pharmaceuticals Pty Ltd.	15 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASD2023	Not Applicable	-	-	CagriSema	zkyedkxuco(qndulbbcoz) = ordfqzbfnw vrrufgpohd (yxxgdrtmzj ) View more	Positive	03 Oct 2023
				Cagrisema	zkyedkxuco(qndulbbcoz) = flhcbmarqj vrrufgpohd (yxxgdrtmzj )
NAASO2022	Not Applicable	-	-	Vehicle control	eoslfrnurn(siaoofeekw) = whzmohelzn lfdgeaqwqx (torkreeguf ) View more	-	21 Nov 2022
				CagriSema	eoslfrnurn(siaoofeekw) = cybimzpddm lfdgeaqwqx (torkreeguf ) View more

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