The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of placebo and semaglutide therapy in 74 KTR at risk of post-transplant diabetes mellitus (PTDM).

Start Date05 Jan 2026

Sponsor / Collaborator

University Health Network

NCT06934655

/ Not yet recruitingPhase 3IIT

Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.

Start Date01 Nov 2025

Sponsor / Collaborator

Children's Hospital Los Angeles

NCT06909006

/ Not yet recruitingPhase 3IIT

Obesity and Semaglutide in Type 1 Diabetes Therapy: a Multicentre, Randomised, Double-Blinded, Placebo-Controlled, Investigator-Initiated Trial

The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.

Start Date01 Oct 2025

Sponsor / Collaborator

Zealand University Hospital

[+1]

100 Clinical Results associated with Semaglutide (Novo Nordisk)

100 Translational Medicine associated with Semaglutide (Novo Nordisk)

100 Patents (Medical) associated with Semaglutide (Novo Nordisk)

325

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

01 May 2025·Diabetes Therapy

PIONEER REAL Italy: Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes

Article

Author: Deinega, Alisa ; Giordano, Carla ; Desenzani, Paolo ; Memoli, Pasqualina ; Faldetta, Maria Cassone ; Gioia, Daniela ; Ventura, Claudio ; Serra, Rosalia ; Gallo, Marco ; Berra, Cesare ; Braae, Uffe Christian ; Memoli, Giuseppe ; Manetti, Francesco ; Bisio, Alessandro ; Paccagnella, Agostino ; Strazzabosco, Marco ; Mirani, Marco ; Marangoni, Alberto ; Anzaldi, Massimiliano ; De Cata, Pasquale ; Girelli, Angela ; Di Loreto, Chiara ; De Cosmo, Salvatore ; Scatena, Alessia ; Manti, Roberta ; Ferrara, Lidia

INTRODUCTION:

The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings.

METHODS:

This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14 mg, and were followed for 34-44 weeks. The primary endpoint was the change in glycated hemoglobin (HbA_1c) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA_1c < 7%, composite endpoints of HbA_1c reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.

RESULTS:

Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40 weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA_1c of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA_1c and BW were - 0.9%-points (- 1.01 to - 0.82; p < 0.0001) and - 3.8 kg (- 4.45 to - 3.24; p < 0.0001), respectively. At EoS, 65.1% achieved HbA_1c < 7%; 25.5% and 19.1% reached HbA_1c reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, p < 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed.

CONCLUSIONS:

In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice.

TRIAL REGISTRATION:

NCT05230615.

01 Apr 2025·DIABETOLOGIA

Once-weekly IcoSema versus once-weekly semaglutide in adults with type 2 diabetes: the COMBINE 2 randomised clinical trial

Article

Author: Chen, Liming ; Benamar, Malik ; Fu, Ariel ; Yabe, Daisuke ; Zueger, Thomas ; Réa, Rosângela ; Riveline, Jean-Pierre ; Nishida, Tomoyuki ; Jódar, Esteban ; Lingvay, Ildiko

Abstract:

Aims/hypothesis:

COMBINE 2 assessed the efficacy and safety of once-weekly IcoSema (a combination therapy of basal insulin icodec and semaglutide) vs once-weekly semaglutide (a glucagon-like peptide-1 analogue) 1.0 mg in individuals with type 2 diabetes inadequately managed with GLP-1 receptor agonist (GLP-1 RA) therapy, with or without additional oral glucose-lowering medications.

Methods:

This 52 week, randomised, multicentre, open-label, parallel group, Phase IIIa trial was conducted across 121 sites in 13 countries/regions. Adults with type 2 diabetes (HbA1c 53.0–85.8 mmol/mol [7.0–10.0%]) receiving GLP-1 RA therapy with or without additional oral glucose-lowering medications were randomly assigned 1:1 to once-weekly IcoSema or once-weekly semaglutide 1.0 mg. The primary endpoint was change in HbA1c from baseline to week 52; superiority of IcoSema to semaglutide 1.0 mg was assessed. Secondary endpoints included change in fasting plasma glucose and body weight (baseline to week 52), and combined clinically significant (level 2; <3.0 mmol/l) or severe (level 3; associated with severe cognitive impairment requiring external assistance for recovery) hypoglycaemia (baseline to week 57).

Results:

Overall, 683 participants were randomised using a Randomisation and Trial Supply Management system to IcoSema (n=342) or semaglutide 1.0 mg (n=341). Mean ± SD baseline characteristics were as follows: HbA1c 64.0±8.2 mmol/mol (8.0±0.7%); diabetes duration 12.6±6.9 years; and BMI 31.1±4.7 kg/m2. From baseline to week 52, mean change in HbA1c was −14.7 mmol/mol (−1.35%-points) in the IcoSema group and −9.88 mmol/mol (−0.90%-points) in the semaglutide group; the estimated treatment difference (ETD) was –4.85 (95% CI −6.13, −3.57) mmol/mol (−0.44 [95% CI −0.56, −0.33]%-points), confirming superiority of IcoSema to semaglutide (p<0.0001). The estimated mean change in fasting plasma glucose from baseline to week 52 was statistically significantly reduced with IcoSema vs semaglutide (−2.48 mmol/l vs −1.41 mmol/l, respectively; ETD −1.07 [95% CI −1.37, −0.76] mmol; p<0.0001). Mean change in body weight from baseline to week 52 was statistically significantly different between groups: +0.84 kg for IcoSema vs −3.70 kg for semaglutide (ETD 4.54 kg [95% CI 3.84, 5.23]; p<0.0001). There was no statistically significant difference in the rate of combined clinically significant or severe hypoglycaemia between IcoSema and semaglutide (0.042 vs 0.036 episodes per person-year of exposure; estimated rate ratio 1.20 [95% CI 0.53, 2.69]; p=0.66). The proportion of participants experiencing gastrointestinal adverse events was similar between treatment groups (IcoSema 31.4%; semaglutide 34.4%).

Conclusions/interpretation:

In people living with type 2 diabetes inadequately managed with GLP-1 RA therapy, with or without additional oral glucose-lowering medications, switching to once-weekly IcoSema in comparison with once-weekly semaglutide 1.0 mg demonstrated superiority in HbA1c reduction, similar rates of clinically significant or severe hypoglycaemia, and similar frequency of gastrointestinal adverse events. However, weight change from baseline to week 52 was statistically significantly in favour of semaglutide 1.0 mg.

Trial registration:

ClinicalTrials.gov NCT05259033

Funding:

This trial was funded by Novo Nordisk

Graphical Abstract:

01 Apr 2025·NATURE MEDICINE

Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial

Article

Author: Tsoukas, Michael A ; Jafar, Adnan ; Pasqua, Melissa-Rosina ; Aboznadah, Wedyan ; Haidar, Ahmad ; Kobayati, Alessandra

Efforts to improve glycemic control in type 1 diabetes are ongoing. We performed a randomized, double-blind, crossover trial to assess semaglutide as adjunct to automated insulin delivery therapy in adults with type 1 diabetes. At each intervention, participants were titrated up to 1 mg or the maximum tolerated dose of semaglutide or placebo over 11 weeks, followed by the use of an automated insulin delivery system for 4 weeks. The primary outcome was the percentage of time spent in the target glucose range of 3.9-10.0 mmol l^-1 during the last 4 weeks of each intervention. Twenty-eight participants were randomized and 24 completed the trial. The primary endpoint was met. Compared to placebo, semaglutide increased time in the target range by a mean 4.8 (s.d. = 7.6) percentage points (P = 0.006), without increasing the time spent below 3.9 mmol l^-1 (P = 0.19) or below 3.0 mmol l^-1 (P = 0.65). While no diabetic ketoacidosis or severe hypoglycemia occurred during any of the interventions, there were two episodes of recurrent euglycemic ketosis without acidosis during semaglutide use. We conclude that semaglutide improves glycemic control with automated insulin delivery compared to placebo. ClinicalTrials.gov registration: NCT05205928.

2,016

News (Medical) associated with Semaglutide (Novo Nordisk)

06 May 2025

·www.novonordisk.com

Novo Nordisk A/S: ECO 2025 - Novo Nordisk semaglutide data shows new health benefits across serious chronic diseases

Bagsværd, Denmark, 6 May 2025 – Novo Nordisk today announced that new data spanning the company’s industry-leading portfolio across metabolic and cardiovascular health will be presented at the upcoming 32 nd European Congress on Obesity (ECO), 11–14 May 2025. The data will further extend the wide-ranging evidence base for semaglutide through real-world evidence studies and additional analysis of the landmark cardiovascular outcomes trial, SELECT, as well as part 1 of the phase 3 ESSENCE trial in metabolic dysfunction-associated steatohepatitis (MASH). Data will also be presented on the wider societal impacts of treating and preventing obesity, alongside analysis of the burden of obesity in adolescents. “Obesity is one of the greatest healthcare challenges we face globally, impacting the lives of hundreds of millions of people. Without effective interventions, the global burden of obesity and its complications will continue to rise,” said Stephen Gough, senior vice president and head of Chief Medical Office at Novo Nordisk. “Our broad and robust semaglutide data presented at ECO, including its impact on weight loss in a real-world setting and its early clinical effect on cardiovascular events and death, significantly adds to the growing body of evidence showing the value of semaglutide to individuals, healthcare systems and society.” “We are dedicated to leading the way in defeating obesity and are pleased to return to ECO to present new, strong semaglutide data,” said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. “Our investment into the understanding and treatment of obesity continues to reveal new insights, with semaglutide showing its potential to improve health in obesity, heart disease and liver disease. Our data shows that semaglutide provides early protection against heart disease even before significant weight loss occurs and that for people in treatment, our digital support solutions have the potential to enhance weight loss further.” Novo Nordisk abstracts to be presented, some of these data for semaglutide are investigational: Obesity is a chronic, multi-factorial disease influenced by biological, psychological, and environmental factors that often puts people on the pathway to other serious chronic diseases, including cardiovascular disease (CVD) and metabolic diseases, such as type 2 diabetes, obesity, and MASH. 1 , 2 , 3 A significant proportion of the cardiovascular risk associated with these diseases is attributable to shared metabolic risk factors. 3 CVD accounts for around 70% of deaths in people living with obesity and is the leading cause of death in people with type 2 diabetes, chronic kidney disease and MASH. 3, 4 , 5 , 6 Obesity is also associated with an increased demand on healthcare services, and a significant cost burden to society. 7 About semaglutide Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), which mimics the effects of the naturally occurring hormone GLP-1. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases. It has a cumulative exposure of over 33 million patient-years since 2018. 8 Semaglutide is marketed under the brand names Wegovy ® (once-weekly semaglutide 2.4 mg injection), Ozempic ® (once-weekly semaglutide 1.0 mg injection), and Rybelsus ® (once-daily oral semaglutide 14 mg). About Wegovy ® In the EU, Wegovy ® is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m 2 or greater (obesity), adults with an initial BMI of 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition and paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. In the US, Wegovy ® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, as well as to reduce excess body weight and maintain weight reduction long term in adults and paediatric patients aged 12 years and older with obesity and in adults with overweight in the presence of at least one weight-related comorbid condition. 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. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information References 1 National Institutes of Health. Clinical Guidelines On The Identification, Evaluation, And Treatment Of Overweight And Obesity In Adults. NHLBI. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Last accessed: November 2024. 2 Marassi M, Fadini GP. The cardio-renal-metabolic connection: a review of the evidence. Cardiovasc Diabetol. 2023 Jul 31;22(1):195. doi: 10.1186/s12933-023-01937-x. PMID: 37525273; PMCID: PMC10391899. 3 Shroff H, VanWagner LB. Cardiovascular Disease in Nonalcoholic Steatohepatitis: Screening and Management. Curr Hepatol Rep. 2020;19(3):315-326. doi:10.1007/s11901-020-00530-0. 4 Jankowski J, Floege J, Fliser D, Böhm M, Marx N: Cardiovascular disease in chronic kidney disease: pathophysiological insights and therapeutic options. Circulation. 2021, 143:1157-72. 5 Khafagy R, Dash S. Obesity and Cardiovascular Disease: The Emerging Role of Inflammation. Front Cardiovasc Med. 2021;8:768119. Published 2021 Oct 25. doi:10.3389/fcvm.2021.768119. 6 Ma, CX., Ma, XN., Guan, CH. et al. Cardiovascular disease in type 2 diabetes mellitus: progress toward personalized management. Cardiovasc Diabetol 21, 74 (2022). https://doi.org/10.1186/s12933-022-01516-6 7 Okunogbe et al. Economic impacts of overweight and obesity: current and future estimates for eight countries BMJ Glob Health 2021;6(10):e006351. 8 Novo Nordisk data on file.

Drug ApprovalPhase 3

05 May 2025

·www.biospace.com

Novo’s Wegovy Inches Closer to Becoming First FDA-Approved GLP-1 Weight-Loss Pill

iStock, Ahmad Darmansyah The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year. The FDA on Friday accepted Novo Nordisk ’s New Drug Application for an oral formulation of its widely popular obesity drug Wegovy for chronic weight management, bringing the Danish drugmaker one step closer to winning the first regulatory approval for a GLP-1 pill specifically for weight-loss. Novo did not provide a specific target action date for oral Wegovy, only announcing in its news release that the FDA’s verdict is expected in the fourth quarter. If approved, Wegovy’s pill form will carry a 25-mg dose of the drug, scheduled for once-daily dosing in adults who are overweight or obese and who have at least one comorbid condition. Supporting Wegovy’s oral bid are results from the Phase III OASIS 4 study. A November 2024 readout showed that daily oral Wegovy could match the weekly injectable in lowering bodyweight, Healio reported at the time. Novo did not provide additional data comparing oral versus injectable Wegovy in its Friday release. OASIS 4 also found that oral Wegovy significantly outperformed placebo, cutting an average of 13.6% of participants’ weight, as opposed to 2.4% in the control group. The oral drug also had a safety pro with its injectable formulation. Wegovy can cause adverse effects like nausea, diarrhea, constipation and abdominal pain. Last month, a Novo spokesperson confirmed to BioSpace that the pharma had filed for approval for oral Wegovy. The spokesperson also clarified that Novo already has an oral GLP-1 on the market. Rybelsus, an early brand of semaglutide, was given the FDA’s go-ahead in September 2019 for oral dosing. But instead of being indicated for chronic weight management, Rybelsus is approved to treat type 2 diabetes. Novo is locked in a close race with Eli Lilly to bring the first weight-loss pill to the market. Last month, Lilly announced that orforglipron, an orally available GLP-1 treatment, significantly lowered blood glucose levels in patients with type 2 diabetes. Analysts at the time were bullish about these findings, with BMO Capital Markets noting that orforglipron achieved “injectable like efficacy.” Study participants also lost 7.9% body weight after orforglipron treatment, as compared with 1.6% in placebo. A few days after the late-stage win, Lilly CEO David Ricks told Fox Business that while the study was primarily in diabetes, the pharma’s first drug application for orforglipron will be for chronic weight management later this year. Lilly will subsequently approval for type 2 diabetes in 2026. The company also promised to manufacture the drug in the U.S.

Clinical ResultPhase 3Drug ApprovalNDA

02 May 2025

·www.fiercepharma.com

Madrigal's Rezdiffra, the first-ever MASH drug, beats sales projections for 4 quarters in a row

Madrigal Pharmaceuticals’ fatty liver disease drug Rezdiffra generated $137 million in sales during the first quarter of 2025, well above analysts’ consensus expectation of $112 million. Since its historic FDA approval in March 2024 as the first medication for the treatment of the prevalent liver disease metabolic dysfunction-associated steatohepatitis (MASH), Madrigal Pharmaceuticals’ Rezdiffra has handily beat Wall Street’s sales projections for the fourth straight quarter.On a roll, Rezdiffra generated $137 million in sales during the first quarter of 2025, well above analysts’ average expectation of $112 million. The haul also marked a sequential increase from the fourth quarter’s $103 million, which also beat consensus, bringing the drug’s sales in the first 12 months on the market to $317 million.“By any measure, this is an exceptional launch,” Madrigal CEO Bill Sibold said on an investor call Thursday.“Importantly, the Rezdiffra launch continues to be driven by strong underlying patient demand,” Leerink Partners analysts wrote in a Thursday note.As of the end of March, more than 17,000 MASH patients were actively taking Rezdiffra, compared with more than 11,800 at year-end 2024, according to Madrigal. Rezdiffra’s speed of adding new patients matches that from other top-tier specialty launches, Sibold said.The launch is still at an early stage, as Madrigal is targeting 315,000 patients who fall under Rezdiffra’s FDA-approved label and are currently treated by the company’s target prescribers. Among the 6,000 top MASH prescribers targeted by Madrigal, 70% have prescribed Rezdiffra, Sibold said. Before Rezdiffra’s approval, investors were worried that the FDA would require patients to undergo a liver biopsy to determine treatment eligibility. Now that the drug’s label doesn’t require that test, a potential restriction by payers has become a new investor concern.A key opinion leader in the MASH field—who leads the fatty liver clinic at an academic center in California that takes care of about 3,000 MASH patients—recently told Leerink that he has not encountered a single payer requiring liver biopsy before granting access to Rezdiffra.The expert indicated that 90% of his patients have remained on Rezdiffra after a year of treatment, with a small percentage of discontinuations related to tolerability or lack of treatment response, according to a Leerink note on Thursday.In what Sibold described as a standard move for medicines, payers may require reauthorization of Rezdiffra after a year of treatment based on a patient’s performance. The company doesn’t see that as an issue, he said, as physicians’ feedback so far suggests the drug's efficacy has exceeded expectations.“Physicians and patients continue to highlight meaningful improvements they see on the efficacy measures that matter most to patients such as liver stiffness, liver fat, liver enzymes, LDL and triglycerides,” Sibold said on the call.Competition may be coming, though, potentially first in the form of Novo Nordisk’s formidable GLP-1 semaglutide later this year.Novo is targeting a market that’s “multiples” the size of Madrigal’s target population of 315,000 patients, Sibold noted. Given that Rezdiffra has only penetrated 5% of its own target population, Madrigal still sees “years of growth” ahead, he said.About 25% of Rezdiffra takers are already on a GLP-1 product, Sibold noted, suggesting that there’s still a need for other MASH treatments despite the GLP-1 drugs having been around for more than a decade, albeit not specifically for MASH.Semaglutide is “only going to accelerate diagnosis and add to that” target, Sibold added, suggesting Novo will expand the market to the benefit of Madrigal as well. Putting potential geographic market expansion in its own hands, Madrigal is expecting a regulatory opinion from the European Medicines Agency and subsequent EU market authorization in mid-2025. The company plans to launch first in Germany in the second half of the year.While Rezdiffra is currently approved for stage F2 and F3 non-cirrhotic MASH, also known as nonalcoholic steatohepatitis (NASH), Madrigal is also aiming to unlock the F4 cirrhotic population.The company will present detailed two-year data from the compensated MASH cirrhosis arm of the phase 3 Maestro-NAFLD-1 trial next week at the European Association for the Study of the Liver Congress. Outcomes data from the large Maestro-NASH Outcomes trial in compensated cirrhosis are expected in 2027.The expansion to F4 cirrhosis is “a key pillar of our long-term NASH leadership strategy,” Sibold said, noting that the indication could double Rezdiffra’s market opportunity.

Drug ApprovalPhase 3

100 Deals associated with Semaglutide (Novo Nordisk)

External Link

KEGG	Wiki	ATC	Drug Bank
D10025	Semaglutide (Novo Nordisk)	A10BJ06	DB13928

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Kidney Diseases	United States	Novo Nordisk A/S	28 Jan 2025
Chronic Kidney Diseases	United States	Novo Nordisk, Inc.	28 Jan 2025
Stroke	Australia	Novo Nordisk Pharmaceuticals Pty Ltd.	16 Dec 2024
Myocardial Infarction	Canada	Novo Nordisk Canada, Inc.	27 Nov 2024
Obesity	United States	Novo Nordisk, Inc.	04 Jun 2021
Overweight	United States	Novo Nordisk, Inc.	04 Jun 2021
Diabetes Mellitus, Type 2	United States	Novo Nordisk, Inc.	05 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	NDA/BLA	United States	Novo Nordisk A/S	30 Apr 2025
Albuminuria	Phase 3	Canada	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Germany	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Netherlands	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Spain	Novo Nordisk A/S	14 Mar 2022
Osteoarthritis, Knee	Phase 3	United States	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Canada	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Colombia	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Denmark	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	France	Novo Nordisk A/S	01 Oct 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05786521 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Insulin Resistance \| Prediabetic State ... View more	20	Semaglutide Injectable Product+Lifestyle Counseling (Semaglutide and Lifestyle Intervention)	jaqdwtmtkh(lxkljujyed) = zrromwzwuc vdlyfsjoci (qnuhtjggux, scjnbzrrzz - chdarnxjeg) View more	-	04 May 2025
				Lifestyle Counseling (Lifestyle Intervention)	jaqdwtmtkh(lxkljujyed) = lcuzffbiut vdlyfsjoci (qnuhtjggux, okywzjuwha - oyelizkyps) View more
NCT04822181 (ESSENCE, PRNewswire \| Pubmed) Manual	Phase 3	Nonalcoholic Steatohepatitis	800	Semaglutide 2.4 mg	jqwwjbiksv(matvcccwej) = cmhnuraiaj ayaiyfhbnc (tzcjnoaefz ) View more	Positive	30 Apr 2025
				Placebo	jqwwjbiksv(matvcccwej) = svgpiigxre ayaiyfhbnc (tzcjnoaefz ) View more
NCT03574597 (SELECT, PRNewswire) Manual	Phase 3	Overweight \| Obesity	17,604	司美格鲁肽2.4mg	tytzzzmijt(vpzdkvzhdp) = noahwhpnmi mgfbsqmxav (srpqsqlwzi ) View more	Positive	03 Apr 2025
				Placebo	-
NCT04998136 (CTgov)	Phase 3	Obesity	150	Placebo (semaglutide 2.4 mg)	grlkiznffy(avefrovjsi) = ujocwqeqso iejirzbzzd (egudvadzxc, 5.8) View more	-	03 Apr 2025
NCT03914326 (SOUL, Pubmed \| N Engl J Med) Manual	Phase 3	Diabetes Mellitus, Type 2	9,650	Oral Semaglutide	jxiyovienn(lqysmucgxs) = npzlcpraza jldhgsbrpx (ydtmziigiy ) View more	Positive	29 Mar 2025
				Placebo	jxiyovienn(lqysmucgxs) = enhbwpdpoo jldhgsbrpx (ydtmziigiy ) View more
NCT05230615 (PIONEER REAL Italy, Pubmed \| Diabetes Ther)	Not Applicable	Diabetes Mellitus, Type 2	445	Oral Semaglutide 3 mg	uzspvllbat(ztkurbrwnl) = jqabdhylcg fhptslsctr (tymispzqix )	Positive	25 Mar 2025
				Oral Semaglutide 7 mg	uzspvllbat(ztkurbrwnl) = fliasahmbo fhptslsctr (tymispzqix )
NCT05520775 (CTgov)	Phase 2	Alcohol Use Disorder \| Smoking	48	Semaglutide (Semaglutide)	qpmkazvjhw(ndhqgjexsa) = dnncpzywjl ojmduiieao (nodmclqmvi, 27.98) View more	-	25 Mar 2025
				Sham/placebo (Sham/Placebo)	qpmkazvjhw(ndhqgjexsa) = wgcdqemtge ojmduiieao (nodmclqmvi, 24.49) View more
NCT03819153 (FLOW, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	3,533	semaglutide (Semaglutide)	rzunobqcag = umsvxxfcxe hwwqtlmeaz (xzckmxrxya, cmfjwnjzqu - vqcpvhzxvx) View more	-	20 Mar 2025
				Placebo (semaglutide) (Placebo)	rzunobqcag = rfmxwnrnhx hwwqtlmeaz (xzckmxrxya, enmdqusiye - zfcwfsxvzc) View more
Drugs Manual	Not Applicable	Obesity	364	Semaglutide	qedppydsee(jeimtiphut) = fdtobnflws nrewcwxexp (sclobldgmr )	Negative	12 Mar 2025
				Control (No Semaglutide)	qedppydsee(jeimtiphut) = rvbrradtlf nrewcwxexp (sclobldgmr )
NCT04560998 (STRIDE, Pubmed \| Lancet) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Peripheral Arterial Disease	792	Semaglutide	jablmtyfuu(icrixcqsyz) = ndkdqoqirj zomvjhvdwu (rhvfiuiyvu, 0.95 - 1.55) View more	Positive	01 Mar 2025
				Placebo	jablmtyfuu(icrixcqsyz) = xfpmqtazcc zomvjhvdwu (rhvfiuiyvu, 0.86 - 1.36) View more

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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.

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Regulation

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

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis