Delving into the Latest Updates on Semaglutide (Novo Nordisk) with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Semaglutide, Semaglutide (Genetical Recombination), Semaglutide (genetical recombination) (JAN)

+ [24]

Target

GLP-1R

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseNervous System DiseasesCardiovascular Diseases+ [7]

Active Indication

Myocardial InfarctionObesityOverweight+ [27]

Inactive Indication

Fibrosis, LiverLiver InjuryPain

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/SNovo Nordisk, Inc.

Gilead Sciences, Inc.

+ [6]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (05 Dec 2017),

Diabetes Mellitus, Type 2

RegulationBreakthrough Therapy (CN)

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Gene Sequence

Sequence Code 50953

Source: *****

The purpose of this research study is to find out if semaglutide is safe and well tolerated in adults with cocaine use disorder who do and do not have human immunodeficiency virus (HIV). Participants will complete a screening process and if you are able to participate, you will be assigned to one of two treatment groups: semaglutide or placebo.
Participants will:
* Visit the clinic once a week for semaglutide or placebo injections
* Visit the clinic once every two weeks for labwork, assessments and/or surveys

Start Date01 Mar 2025

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT06639464 / Not yet recruitingPhase 2IIT

Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial

The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.

Start Date01 Mar 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

100 Clinical Results associated with Semaglutide (Novo Nordisk)

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100 Translational Medicine associated with Semaglutide (Novo Nordisk)

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

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1,472

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

01 Mar 2025·Endocrine Metabolic & Immune Disorders-Drug Targets

Efficacy and Safety of Semaglutide in Weight Loss of Non-diabetic People

Article

Author: Wu, Hong-Yan ; Song, Cai-E ; Dai, Xue-Mei ; Wang, Yan

Objective::

The study aimed to investigate the efficacy and safety of semaglutide in weight loss in non-diabetic people.

Methods::

In this study, 84 non-diabetic people who used semaglutide to lose weight in the outpatient department of our hospital from January 1, 2022, to June 30, 2022, were enrolled and compared for changes in body weight, waist circumference, Body Mass Index (BMI), fasting blood glucose, blood pressure, pulse, and body composition (body fat ratio, visceral fat area, and skeletal muscle) before treatment and 12 weeks after the treatment to analyze the weight loss efficacy and safety.

Results::

After administering semaglutide 0.25 mg, 0.5 mg, 0.75 mg, or 1.0 mg subcutaneously once a week for 12 weeks, 84 participants in this study obtained an average weight loss of 5.91 ± 3.37 kg, equivalent to 6.15 ± 4.28% of baseline body weight, and there was also a significant reduction in visceral fat area and a slight reduction in blood pressure. The most common adverse reactions included gastrointestinal reactions (nausea, vomiting, and diarrhea), which were mild and subsided within 1-2 days. No severe adverse reaction, such as hypoglycemia and hypotension, was observed.

Conclusion::

Low-dose semaglutide has been found to be effective and safe for short-term weight loss in non-diabetic people.

01 Feb 2025·Contemporary Clinical Trials

The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease

Article

Author: Boucher, Robert ; Akramimoghaddam, Farahnaz ; Wei, Guo ; Greene, Tom ; Oro, Evan G ; Katkam, Niharika ; Zheng, Ann ; Bjordahl, Terrence ; Beddhu, Srinivasan ; Mohammed, Azeem ; Lee, Edison ; Bissada, George ; Anand, Shuchi ; Chertow, Glenn M ; Lyden, Kate ; Takyi, Augustine ; Christensen, Jesse C ; Sarwal, Amara ; Chakravartula, Akhil Ramanujam

BACKGROUND:

Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD. Therefore, we aimed to determine whether guided resistance training ± oral semaglutide co-intervention improves adherence and/or persistence of the SLIMM intervention.

METHOD/DESIGN:

The SLIMM-2 is a two-center study designed with a 3-month sedentary activity coaching (SLIMM) followed by a 9-month randomized controlled trial with three arms: SLIMM + standard of care resistance training + oral placebo, SLIMM + guided resistance training + oral placebo, or SLIMM + guided resistance training + oral semaglutide. The study is recruiting persons with CKD (eGFR 20 to ≤60 ml/min/1.73 m²). ActivPAL, a wearable tri-axial accelerometer, is used to assess outcomes including sedentary duration (primary outcome), stepping duration and the average number of steps per day. Additional outcomes include 6-min walk distance and body fat percentage. Persons randomized to standard of care resistance training will be encouraged to maintain individualized physical activity goals; those randomized to guided resistance training will attend guided sessions per month and be prescribed daily independent exercises.

RESULTS:

Enrollment, interventions, and follow-up are ongoing.

CONCLUSIONS:

Results from the SLIMM-2 study are expected to inform clinical practice, with the potential to enhance physical health and functioning among persons with CKD.

01 Feb 2025·JOURNAL OF PHARMACY PRACTICE

Problematic Pharmacokinetics: A Case of Recurrent Pancreatitis Post Discontinuation of a Glucagon-Like Peptide 1 Receptor Agonists

Article

Author: Ledford, Jack D. ; Morehouse, Zachary P.

Glucagon-like peptide 1 receptor agonists (GLP-1RA) are guideline recommended agents for the treatment of type 2 diabetes mellitus (T2DM) and select agents (liraglutide and semaglutide) are FDA approved as anti-obesity pharmacotherapy options. These drugs act on the incretin hormone system within the body to revive insulin excretion, delay gastric emptying, and inhibit the production of glucagon from pancreatic alpha cells. Acute pancreatitis is a serious condition that may have a fatal outcome. It has been shown, and is now part of the prescribing information label, that GLP-1RA agents can cause changes in the pancreas that may ultimately lead to pancreatitis. We describe the case of a 53-year-old female patient with uncontrolled type II diabetes mellitus, who experienced multiple episodes of pancreatitis, from what we suspect was due to repeated exposure to the GLP-1 RA agent, semaglutide. After discontinuation of semaglutide, our patient experienced another episode of pancreatitis roughly 15-week later; which we believe may be due to the patient experiencing the effects of a smoldering pancreas brought on by repeated injury and prolonged circulation of semaglutide post-discontinuation.

1,618

News (Medical) associated with Semaglutide (Novo Nordisk)

23 Dec 2024

·pipelinereview.com

Wave Life Sciences Announces Submission of First Clinical Trial Application for WVE-007 (siRNA Targeting INHBE) in Obesity

WVE-007 is a novel approach for treating obesity and is designed to silence INHBE to achieve healthy, sustainable weight loss through fat burning, muscle maintenance and the potential for once or twice-annual administration WVE-007 is Wave’s first siRNA program to enter clinical development and uses best-in-class oligonucleotide chemistry and GalNAc delivery Wave expects to initiate the first-in-human study of WVE-007 in 1Q 2025 CAMBRIDGE, MA, USA I December 23, 2024 I Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced the submission of its first clinical trial application (CTA) for WVE-007 in obesity. WVE-007 is an investigational GalNAc-conjugated small interfering RNA (siRNA) designed to silence Inhibin βE (INHBE) gene expression, which would induce fat burning (lipolysis) to decrease body weight without impacting muscle mass. Wave expects CTA approval and initiation of the first-in-human study of WVE-007 in the first quarter of 2025. “Our WVE-007 program, which uses Wave’s best-in-class GalNAc-siRNA capabilities with proprietary chemistry, has potential to be dosed once or twice annually and may ultimately be used across the obesity treatment continuum for sustainable weight loss and cardiometabolic risk reduction,” said Paul Bolno, MD, MBA, President and Chief Executive Officer at Wave Life Sciences. “With a growing understanding of human genetics and opportunities to directly impact adipose tissue, INHBE has emerged as an exciting, novel therapeutic target to address obesity, without the challenges of current standard-of-care therapeutics.” Human genetics provide strong evidence for INHBE as a therapeutic target. Individuals who have a protective loss-of-function mutation in the INHBE gene have a healthier cardiometabolic profile, including less abdominal fat, lower triglycerides, and lower risk of type 2 diabetes and cardiovascular disease. WVE-007 is designed to induce this healthy phenotype through INHBE gene silencing, leading to fat burning and improvements in metabolic health. In preclinical studies using a mouse model of diet induced obesity (DIO), a single dose of Wave’s INHBE siRNA led to weight loss on par with semaglutide, with no muscle loss. When administered as an add-on to semaglutide, a single dose doubled the amount of weight loss. In another study, Wave’s INHBE siRNA also prevented weight regain when semaglutide treatment was discontinued. Wave’s first-in-human study of WVE-007 is a Phase 1 clinical trial in adults living with overweight or obesity. The trial is designed to assess safety, tolerability, pharmacokinetics, and biomarkers for target engagement, as well as body composition and metabolic health. About Wave Life Sciences Wave Life Sciences (Nasdaq: WVE) is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave’s RNA medicines platform, PRISM ® , combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Its toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Wave’s diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave is headquartered in Cambridge, MA. For more information on Wave’s science, pipeline and people, please visit www.wavelifesciences.com and follow Wave on X (formerly Twitter) and LinkedIn . SOURCE: Wave Life Sciences

Phase 1IND

23 Dec 2024

·endpts.com

FDA approves Lilly's Zepbound for sleep apnea, likely cracking open Medicare market

Eli Lilly’s weight loss juggernaut Zepbound has been approved in the US to treat sleep apnea, and the label expansion could open the door to Medicare coverage for the drug for the first time. Friday’s FDA approval is for patients with moderate-to-severe obstructive sleep apnea and obesity, the FDA said . Zepbound, approved a year ago, is already one of the company’s top-selling drugs, bringing in $3 billion in revenue in the first nine months of the year, much of that from patients with commercial health insurance and who pay out of pocket. But so far the drug hasn’t been covered by Medicare, which doesn’t pay for weight loss treatments but but will cover them for other conditions — many of which can be related to obesity. While the Biden administration has proposed dropping those restrictions (and it’s unclear how the incoming Trump administration might act), in the short term the approval should expand the market. “These indications will help [Lilly] build access for Zepbound, particularly in the Medicare population,” Morgan Stanley analysts told investors in October. In the SURMOUNT-OSA 1 readout last summer, Lilly found that 43.0% of patients not using a pressurized airway device, often known as a PAP, and who got the highest dose of Zepbound met the criteria for disease resolution. In SURMOUNT-OSA 2, which included patients who were using PAP therapy, 51.5% reported disease resolution. That was in addition to significant weight loss that’s been seen in other trials of the drug. Obesity is a well-known risk factor for sleep apnea , and reducing patients’ weight can help. “Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with” obstructive sleep apnea, Patrik Jonsson, president of Lilly’s cardiometabolic health unit, said in a news release. Wall Street eventually expects GLP-1s to be part of the standard of care in obstructive sleep apnea, though it’s unclear whether that means some patients will forgo the use of medical devices like continuous positive airway pressure machines that help push air into breathing pathways to keep them open. The Wall Street Journal reported earlier this year that Jefferies analysts expect the label expansion in sleep apnea could contribute an extra $5 billion in sales for Zepbound. “The approval of obstructive sleep apnea will help us with employer opt-in,” Jonsson said in October during a third-quarter earnings call. “On top of that, it also opens up the door for access in Medicare and with the decision that CMS announced back in April this year, we are confident that we will gain access out of OSA in Medicare.” In March, when the FDA approved Novo Nordisk’s competing drug Wegovy to reduce cardiovascular events, the CMS within weeks announced that Medicare Part D plans could cover the drug for the new indication. It was an important first step, though some in the industry have questioned how it will play out. “Can does not mean they must or they will,” said Ted Kyle, who runs an obesity advocacy organization called ConscienHealth. Moving into new indications is part of a sweeping strategy to put GLP-1s like Zepbound or Wegovy to test in a wide range of conditions ranging from Alzheimer’s disease to alcohol addiction. Lilly has said it also aims to get Zepbound approved for heart failure with preserved ejection fraction and atherosclerotic cardiovascular disease.

Clinical ResultDrug Approval

23 Dec 2024

·www.drugs.com

GLP-1 Zepbound Is Approved As First Drug For Sleep Apnea

MONDAY, Dec. 23, 2024 -- The U.S. Food and Drug Administration (FDA) has approved the first prescription medication specifically for treating obstructive sleep apnea (OSA): the weight-loss drug Zepbound . In a news release published Dec. 20, the FDA stated that Zepbound, part of the GLP-1 receptor agonist medicines that include Ozempic , was cleared to treat moderate to severe OSA in individuals with obesity. According to drugmaker Eli Lilly , the treatment is intended for use alongside a reduced-calorie diet and increased physical activity. “Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Dr. Sally Seymour , director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a news release. “This is a major step forward for patients with obstructive sleep apnea.” OSA, a condition affecting as many as 30 million Americans, is characterized by breathing disruptions during sleep caused by blocked airflow. Weight loss has long been recognized as an effective strategy to reduce OSA severity. "Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences," Patrik Jonsson , president of Lilly Cardiometabolic Health, said in a news release from the company. In clinical trials, he noted, nearly half of Zepbound users saw such significant improvements that their OSA symptoms resolved. FDA approval for Zepbound in treating sleep apnea was based on two previous Eli Lilly-sponsored trials published in the New England Journal of Medicine involving nearly 470 participants, some of whom were using continuous positive airway pressure (CPAP) machines, a standard treatment for OSA. The trials assessed participants using the apnea-hypopnea index (AHI), which measures the frequency of breathing interruptions during sleep. In one trial where participants did not use CPAP, Zepbound reduced AHI events by an average of 25 per hour after one year, compared to a reduction of just five events in the placebo group. In the trial involving CPAP users, Zepbound reduced events by 29 per hour on average, versus six in the placebo group. Participants on Zepbound also experienced substantial weight loss -- averaging 18% to 20% of their body weight (approximately 45 to 50 pounds) over the course of a year -- compared to 1.6% to 2.3% for those on placebo. Zepbound, which was first approved for weight management in November 2023, now offers new hope for those with obesity and obstructive sleep apnea, Eli Lilly reported. The FDA approval is only for people with obesity, but it could help those with sleep apnea get Medicare coverage, which doesn’t cover drugs just for weight loss, according to a report. The company has emphasized its commitment to accessibility, offering patient support programs, including a lower-cost vial option, to help ease financial barriers. However, without insurance, monthly costs can still exceed $1,000. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalClinical Result

100 Deals associated with Semaglutide (Novo Nordisk)

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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
Myocardial Infarction	CA	Novo Nordisk Canada, Inc.	27 Nov 2024
Obesity	US	Novo Nordisk, Inc.	04 Jun 2021
Overweight	US	Novo Nordisk, Inc.	04 Jun 2021
Diabetes Mellitus, Type 2	US	Novo Nordisk, Inc.	05 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	CN	Novo Nordisk A/S	26 Aug 2024
Vascular Diseases	Phase 3	US	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	JP	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	AR	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	AU	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	BR	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	BG	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	CA	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	CO	Novo Nordisk A/S	01 Mar 2023
Vascular Diseases	Phase 3	DK	Novo Nordisk A/S	01 Mar 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05822830 (SURMOUNT-5, Company_Website) Manual	Phase 3	Obesity	751	Zepbound (tirzepatide)	dozodulyad(csczztraql) = grdwkonczn supldyvxob (nazmjmdwyn ) View more	Superior	04 Dec 2024
				Wegovy (semaglutide)	dozodulyad(csczztraql) = ealosoyeyz supldyvxob (nazmjmdwyn ) View more
NCT04251156 (STEP7, CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Obesity	375	Semaglutide (Semaglutide 2.4 mg)	huhjdoxjzd(szqmpjqjai) = riwssyrlpn rlglcobqzf (ruzbbgyumi, iokoyfrxsu - jvkufkfwry) View more	-	29 Nov 2024
				placebo+semaglutide (Placebo)	huhjdoxjzd(szqmpjqjai) = lhigqawvls rlglcobqzf (ruzbbgyumi, ujgnunyloj - kwzttqdkgs) View more
Pubmed Manual	Not Applicable	Alcohol Use Disorder	227,866	Semaglutide	qnyhjoxcgo(qgaaaoljkj) = A total of 133 210 individuals (58.5%) experienced AUD hospitalization. Semaglutide (4321 users) was associated with the lowest risk (AUD: adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and use of liraglutide (2509 users) with the second lowest risk (AUD: aHR, 0.72; 95% CI, 0.57-0.92) of AUD hospitalization. zdgkjawmwg (mjdoyjylji ) View more	Positive	13 Nov 2024
				Liraglutide
STRIDE (NEWS \| Corporate Publications) Manual	Phase 3	Peripheral Arterial Disease	-	Ozempic (semaglutide)	ilblsbidiz(pyvvybrjqf) = euekhpnumi bocfyfdyjw (xuknymcish )	Positive	07 Nov 2024
				Placebo	ilblsbidiz(pyvvybrjqf) = tpvsgtkxuh bocfyfdyjw (xuknymcish )
NCT06489457 (Pubmed \| Diabetes Obes Metab)	Phase 3	-	25	Semaglutide 1 mg/week	kfmpukamwk(wodytbzeny) = fblgolusul xionzrtoyv (jslhysizcp, 2 - 5.5)	Positive	07 Nov 2024
				Testosterone undecanoate 1000 mg/10-12 weeks	kfmpukamwk(wodytbzeny) = xsklpyrkbo xionzrtoyv (jslhysizcp, 2 - 3.5)
NCT05564117 (OASIS 4, Obesity Week) Manual	Phase 3	Obesity	-	Oral Semaglutide 25 mg	vggunlforl(jhybagmpzi) = oxbcrclqvn djefysizwb (jnnnqvfbsi ) View more	Positive	06 Nov 2024
				Placebo	vggunlforl(jhybagmpzi) = zwfmthglka djefysizwb (jnnnqvfbsi ) View more
NCT05486065 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Overweight	245	Semaglutide (Semaglutide 2.0 mg)	zduhkicgwn(djvscvzxqm) = bdbvtixete nigrcichsx (mmfguyvhsj, eoudiyaiwa - dyhjerdtor) View more	-	05 Nov 2024
				Semaglutide (Semaglutide 8.0 mg)	zduhkicgwn(djvscvzxqm) = xdcikuuvyx nigrcichsx (mmfguyvhsj, qxattnsqem - yngcjxoufl) View more
NCT03574597 (SELECT, PRNewswire) Manual	Phase 3	Overweight \| Obesity	-	Semaglutide 2.4 mg	cwhukifmir(axipgefzik) = dwxzakcgaf xkbtuyjmtv (kvzeizkjzd ) View more	Positive	03 Nov 2024
				Placebo	cwhukifmir(axipgefzik) = xetfygnypt xkbtuyjmtv (kvzeizkjzd ) View more
NCT04822181 (ESSENCE, Company_Website) Manual	Phase 3	Nonalcoholic Steatohepatitis	1,200	Semaglutide 2.4 mg	fwtonlzfzw(zhqpdiyufy) = jrzxkishgm iueqgbrtzh (gaqvtmfjvv ) Met View more	Positive	01 Nov 2024
				Placebo	fwtonlzfzw(zhqpdiyufy) = ombzxevsfb iueqgbrtzh (gaqvtmfjvv ) Met View more
NCT05064735 (STEP 9, Pubmed) Manual	Phase 3	Obesity \| Osteoarthritis, Knee	407	Semaglutide 2.4 mg	evkwjsrbnb(lxaarctwti) = ktkwgpqbkm esufdooyly (rjhwiimypx ) View more	Positive	31 Oct 2024
				Placebo	evkwjsrbnb(lxaarctwti) = poaywsrrmr esufdooyly (rjhwiimypx ) View more