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更新于：2026-07-27
Semaglutide/Cagrilintide
更新于：2026-07-27
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最高研发阶段(中国)临床3期 |
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结构/序列
Sequence Code 50953
当前序列信息引自: *****
Sequence Code 720102737
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关联
26
项与 Semaglutide/Cagrilintide 相关的临床试验NCT07357740
A Phase 2 Study to Compare Two Presentations of CagriSema in Participants With Type 2 Diabetes
NCT07282613
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes
NCT07357766
A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity
100 项与 Semaglutide/Cagrilintide 相关的临床结果
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100 项与 Semaglutide/Cagrilintide 相关的转化医学
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100 项与 Semaglutide/Cagrilintide 相关的专利（医药）
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29
项与 Semaglutide/Cagrilintide 相关的文献（医药）2026-08-01Lancet Diabetes & Endocrinology
Cagrilintide–semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study
Article
作者: Buse, John B ; Pedersen, Sue D ; Fabricius, Therese Wilbek ; Jain, Akshay B ; Bajaj, Harpreet S ; Donaldson, Lucienne ; Dalskov, Stine-Mathilde ; Pratley, Richard E ; Haluzík, Martin ; Lingvay, Ildiko ; Hansen Duus, Helene H
BACKGROUND:
The amylin receptor agonist cagrilintide and the GLP-1 receptor agonist semaglutide have complementary effects on glycaemic control and bodyweight. We aimed to investigate the efficacy and safety of a fixed-dose combination of cagrilintide and semaglutide (cagrilintide-semaglutide; known as CagriSema) versus semaglutide or cagrilintide for glycaemic control in people with type 2 diabetes and overweight or obesity.
METHODS:
REIMAGINE 2 was a randomised, double-blind, placebo-controlled and active-controlled, parallel-group study conducted in 30 countries (trial sites included university hospitals, health-care centres, research centres, and other centres). Participants aged 18 years or older with inadequately controlled type 2 diabetes (HbA1c 7·0-10·5% [53-91 mmol/mol]) receiving metformin with or without an SGLT2 inhibitor, and a BMI of 25 kg/m2 or more, were randomly assigned (8:8:2:8:8:1:1) to receive once-weekly subcutaneous cagrilintide 2·4 mg plus semaglutide 2·4 mg (hereafter cagrilintide-semaglutide [2·4 mg each]), semaglutide 2·4 mg, cagrilintide 2·4 mg, cagrilintide 1·0 mg plus semaglutide 1·0 mg (hereafter cagrilintide-semaglutide [1·0 mg each]), semaglutide 1·0 mg, or corresponding placebo for 68 weeks. Randomisation was done using a web-based system with blocked randomisation (block size 36) and stratification according to inclusion in the continuous glucose monitoring subgroup, HbA1c less than 8·5% at screening (yes or no), and country of participation (Japan; yes or no). The study participants, investigators, and study sponsor staff were masked to treatment allocation within dose level throughout the study. The primary endpoint was change in HbA1c from baseline to week 68 with cagrilintide-semaglutide (2·4 mg each) versus semaglutide 2·4 mg in the full analysis set; safety was assessed in all participants who received at least one dose of study product. This study is registered with ClinicalTrials.gov (NCT06065540) and is complete.
FINDINGS:
From Oct 10, 2023, to July 29, 2024, 3593 people were screened for eligibility, 2713 of whom were randomly assigned to cagrilintide-semaglutide (2·4 mg each; n=603), semaglutide 2·4 mg (n=605), cagrilintide 2·4 mg (n=152), cagrilintide-semaglutide (1·0 mg each; n=595), semaglutide 1·0 mg (n=609), or placebo (pooled 2·4 mg and 1·0 mg; n=149). 1164 (42·9%) of 2713 were female, 1549 (57·1%) were male, and 2207 (81·3%) were White. Of the randomly assigned participants, 2595 (95·7%) completed the study and 2376 (87·6%) were on treatment at week 68. Mean baseline HbA1c was 8·2% (SD 0·9). For the primary endpoint using the efficacy estimand, mean HbA1c change was significantly greater with cagrilintide-semaglutide (2·4 mg each) versus semaglutide 2·4 mg (-1·91 percentage points [SE 0·04] vs -1·75 percentage points [0·04]; estimated treatment difference -0·16 percentage points [95% CI -0·27 to -0·05]; p=0·0035). Adverse events were reported in 524 (86·9%) of 603 participants in the cagrilintide-semaglutide (2·4 mg each) group, 491 (81·2%) of 605 in the semaglutide 2·4 mg group, 125 (82·2%) of 152 in the cagrilintide 2·4 mg group, 485 (81·6%) of 594 in the cagrilintide-semaglutide (1·0 mg each) group, 477 (78·5%) of 608 in the semaglutide 1·0 mg group, and 105 (70·5%) of 149 in the placebo group. The most common adverse events in the active treatment groups were gastrointestinal disorders.
INTERPRETATION:
Cagrilintide-semaglutide (2·4 mg each) was superior to semaglutide 2·4 mg in reducing HbA1c in participants with type 2 diabetes receiving metformin with or without an SGLT2 inhibitor. The safety profile of cagrilintide-semaglutide was consistent with the GLP-1 receptor agonist class and previous safety data for cagrilintide. These findings support the added benefit of cagrilintide-semaglutide (2·4 mg each) versus semaglutide 2·4 mg for glycaemic control.
FUNDING:
Novo Nordisk.
2026-07-01Endocrinology, diabetes & metabolism
Comparative Effectiveness of
CagriSegma
, Semaglutide, Cagrilintide and Tirzepatide in the Management of Overweight and Obesity: A Network Meta‐Analysis of Randomized Clinical Trials
Article
作者: Hamarsheh, Sultan ; Zahran, Anwar ; Majadleh, Saleem ; Jaber, Abdel Rahman ; Andonie, Celina R. ; Ayesh, Hazem ; Abu‐Khazneh, Omar
ABSTRACT:
Background:
Obesity is a chronic, progressive disease affecting over 1 billion adults worldwide, linked to serious comorbidities, including diabetes, hypertension, and cardiovascular disease and associated with increased mortality. Achieving clinically meaningful weight loss is critical to reducing cardiometabolic risk. Tirzepatide, semaglutide, cagrilintide and their combination (CagriSema) have demonstrated efficacy in clinical trials; however, no direct head‐to‐head studies have compared all advanced anti‐obesity medications. This network meta‐analysis examines their comparative efficacy and safety.
Methods:
We systematically searched PubMed, Scopus and Cochrane Central for randomized controlled trials comparing these medications with placebo in adults with overweight or obesity. Outcomes included changes in percent body weight, absolute weight, waist circumference, BMI, patients achieving ≥ 5% to ≥ 20% weight loss, HDL‐C and safety outcomes (AEs, serious AEs, gastrointestinal AEs and treatment discontinuation). Random‐effects model and network meta‐analysis methods were employed.
Results:
Twenty‐five trials involving 12 interventions met the inclusion criteria. Tirzepatide 15 mg resulted in the greatest percent weight reduction (MD −17.97%), followed by CagriSema (MD −17.84%) and semaglutide 7.2 mg (MD −14.66%). At the ≥ 20% weight‐loss threshold, CagriSema demonstrated marked superiority (RR 27.82), followed by tirzepatide 15 mg (RR 23.70). Gastrointestinal adverse events increased with all treatments (RR 1.33–1.91), and treatment discontinuation was highest with semaglutide 7.2 mg (RR 3.09). Serious adverse events remained comparable to placebo across all regimens.
Conclusion:
Tirzepatide 15 mg and CagriSema achieve the greatest weight reduction, including ≥ 20% body weight loss. Gastrointestinal adverse events rise with treatment intensity, while serious adverse events remain comparable to placebo. These findings support dual‐pathway and combination incretin therapies as preferred options for patients requiring substantial weight loss. Treatment selection should be individualized based on comorbidity burden, tolerability and weight loss goals, recognizing that ≥ 5% weight loss improves metabolic parameters while ≥ 10% is needed for meaningful comorbidity reduction. Future head‐to‐head trials are needed.
2026-06-01DIABETES OBESITY & METABOLISM
Efficacy and Safety of Cagrilintide and Cagrisema Versus Semaglutide as Anti‐Obesity Medications: A Systematic Review, Meta‐Analysis and Meta‐Regression
Review
作者: Hassan, Muhammad ; Ibrahim, Ahmed ; Ahsan, Muhammad ; Tahir, Muhammad ; Khan, Ghulam Taha ; Bin Shafiq, Shaheer ; Hussain, Muhammad ; Ahmed, Muhammad ; Islam, Faisal ; Uddin, Ammad ; Waqas, Saad Ahmed
ABSTRACT:
Background:
Obesity is a complex chronic disease requiring effective long‐term management. We performed a systematic review and meta‐analysis to evaluate the efficacy and safety of cagrisema and cagrilintide monotherapy compared with semaglutide in individuals with obesity.
Methods:
We searched MEDLINE, Embase, Scopus, Cochrane, and
ClinicalTrials.gov
for randomized controlled trials accessing cagrisema or cagrilintide versus semaglutide for weight loss. Efficacy outcomes were percentage change in body weight, absolute change in body weight, fasting plasma glucose, HbA1c, and BMI. Lipid parameters included total cholesterol, LDL‐C, HDL‐C, VLDL‐C, and triglycerides. A random‐effects model was used to estimate mean differences (MD) or risk ratios (RR) with 95% CIs.
Results:
Three RCTs (
n
= 3545) were included. Cagrisema produced significantly greater percentage [MD −7.47% (95% CI: −10.58, −4.36);
p
< 0.001] and absolute [MD −7.60 kg (95% CI: −10.33, −4.86);
p
< 0.001] weight loss than semaglutide. Cagrilintide monotherapy weight loss was comparable to semaglutide. Lipids parameters were mostly similar between groups, though LDL‐C was modestly higher with combination therapy versus semaglutide [MD 0.29 mmol/L (95% CI: 0.02, 0.55);
p
= 0.03]. Overall and serious adverse events were comparable between cagrisema and semaglutide, but combination therapy increased administration‐site conditions [RR 3.27 (95% CI: 1.27, 8.46)] and nausea [RR 1.64 (95% CI: 1.01, 2.66)]. Cagrilintide monotherapy had a higher risk of serious adverse events [RR 1.83 (95% CI: 1.03, 3.24)] compared to semaglutide.
Conclusion:
Cagrisema is more effective than semaglutide in reducing weight and increasing glycemic control. Cagrisema is safe and has a comparable side effect profile to currently accepted treatments. This regimen has enormous potential in dual‐agonist therapy for obese patients.
100 项与 Semaglutide/Cagrilintide 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 糖尿病 | 申请上市 | 加拿大 | 2026-03-01 | |
| 肥胖 | 申请上市 | 美国 | 2025-12-19 | |
| 2型糖尿病 | 临床3期 | 美国 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 日本 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 奥地利 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 加拿大 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 德国 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 匈牙利 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 印度 | 2023-02-01 | |
| 2型糖尿病 | 临床3期 | 爱尔兰 | 2023-02-01 |
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临床结果
临床结果
适应症
分期
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临床3期 | 809 | 壓鹹築鹹膚餘範繭鬱築(壓範窪顧壓淵艱製獵蓋) = 網窪鑰鹽構積構廠餘餘 鹽網鑰鑰糧積糧鹽膚範 (窪窪壓餘獵觸積襯鑰夢 ) 更多 | 不佳 | 2026-02-23 | |||
壓鹹築鹹膚餘範繭鬱築(壓範窪顧壓淵艱製獵蓋) = 衊鬱襯齋遞壓願築壓鏇 鹽網鑰鑰糧積糧鹽膚範 (窪窪壓餘獵觸積襯鑰夢 ) 更多 | |||||||
临床3期 | 1,206 | Cagrilintide-Semaglutide 2.4 mg | 築餘繭築築夢鏇鏇簾壓(鏇築廠艱壓廠窪襯鏇淵) = 製齋艱憲壓餘窪壓襯選 艱製繭繭築選廠構網顧 (顧網製鑰齋窪醖獵憲餘 ) | 积极 | 2025-08-14 | ||
Placebo | 築餘繭築築夢鏇鏇簾壓(鏇築廠艱壓廠窪襯鏇淵) = 繭蓋鬱醖鹹鹽網壓壓觸 艱製繭繭築選廠構網顧 (顧網製鑰齋窪醖獵憲餘 ) | ||||||
临床3期 | 1,206 | 積觸顧鏇繭夢範夢觸構(鑰製窪築簾構簾鏇鏇鏇) = 廠獵遞鏇鏇顧餘繭衊網 衊鏇築願繭壓願壓構壓 (膚膚窪艱壓襯糧壓廠願 ) 更多 | 不佳 | 2025-03-10 | |||
Placebo | 積觸顧鏇繭夢範夢觸構(鑰製窪築簾構簾鏇鏇鏇) = 製鹽膚鹽鹹製艱網積構 衊鏇築願繭壓願壓構壓 (膚膚窪艱壓襯糧壓廠願 ) 更多 |
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