semaglutide once weekly (NN9904) / Novo Nordisk - LARVOL DELTA

Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=170 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion

Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction (Canada Newswire) - "Novo Nordisk announced today that Wegovy (semaglutide injection) is now approved to reduce the risk of non-fatal myocardial infarction in adults with established cardiovascular disease and BMI equal to or greater than 27 kg/m2. It is the first Health Canada approved treatment to support both chronic weight management and to reduce the risk of non-fatal MI....Health Canada's non-fatal MI indication for Wegovy is based on results of the Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity (SELECT) trial."

Canada approval • Diabetes • Metabolic Disorders • Obesity

Number 3 Top Cardiometabolic Story of 2023: The SELECT trial, published in November showed that #semaglutide reduced the risk of cardiovascular death by 20% in patients with obesity without diabetes.

Sagimet Biosciences Announces Oral Presentation of Preclinical Results of FASN Inhibitor in Combination with Semaglutide at the 7th Obesity and NASH Drug Development Summit (Yahoo Finance) - "Sagimet Biosciences Inc...will present preclinical data at the 7th Obesity and NASH Drug Development Summit on November 28, 2023, in Boston. The presentation details an evaluation of Sagimet’s FASN inhibitor alone or in combination with semaglutide in a preclinical mouse model of nonalcoholic steatohepatitis (NASH), using an artificial intelligence (AI) based digital pathology platform (FibroNestTM, Pharmanest Inc., Princeton, USA) to assess fibrosis....'Our immediate focus remains on advancing denifanstat as a potential monotherapy and we remain on track to report topline results of our FASCINATE-2 Phase 2b clinical trial, including biopsy data, in the first quarter of next year'."

P2b data • Preclinical • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Penn Medical Group Introduces Semaglutide in Comprehensive Health Management Program (PRNewswire) - "Penn Medical Group...is excited to announce the introduction of semaglutide, an innovative treatment for weight management, to its suite of healthcare offerings. This comes at a time when the search for effective weight loss treatments is paramount, given the high prevalence of obesity and overweight conditions in the U.S."

Commercial • Diabetes • Metabolic Disorders

[PREPRINT] Comparative Effectiveness of Semaglutide and Tirzepatide for Weight Loss in Adults with Overweight and Obesity in the US: A Real-World Evidence Study (medRxiv) - "A larger proportion of patients on tirzepatide, compared to semaglutide, achieved weight reductions ≥5% (81.8% vs. 64.6%), ≥10% (62.1% vs. 38.0%), and ≥15% (42.3% vs 19.3%) within 1 year on treatment, yielding hazard ratios of 1.76 (1.68 - 1.85) for 5%, 2.42 (2.25 - 2.59) for 10%, and 3.04 (2.73 - 3.38) for 15% weight loss. Patients on tirzepatide experienced larger changes in percentage of body weight lost at 3 months on treatment (difference [95% CI]) (-2.3% [-2.5% , -2.2%]), 6 months on treatment (-4.3% [-4.6%, -3.9%]) , and 12 months on treatment (-7.2% [-8.3% , -6.2%]). Hazards for all gastrointestinal (GI) adverse events were similar between groups."

Preprint • Real-world evidence • Diabetes • Metabolic Disorders • Obesity

Sagimet Biosciences Presents Preclinical Results Supporting the Therapeutic Potential of its FASN inhibitor in Combination with Semaglutide and a Comprehensive Lipidomic Analysis of Interim FASCINATE-2 Data at AASLD - The Liver Meeting 2023 (GlobeNewswire) - "Sagimet Biosciences Inc...announced the presentation of preclinical results detailing artificial intelligence (AI) based digital pathology of Sagimet’s FASN inhibitor alone or in combination with semaglutide in a preclinical mouse model of nonalcoholic steatohepatitis (NASH)....A single treatment of a FASN inhibitor or semaglutide - improved the NAFLD activity score, or NAS, (NAS ≥ 1 point, 47% and 56%, respectively). The combination of a FASN inhibitor and semaglutide showed further improvement of NAS (94%, p20% in NASH mice, alone, or in combination with a FASN inhibitor."

Preclinical • Diabetes • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Semaglutide Does Not Worsen Diabetic Retinopathy Status (HCPLive) - "A majority of patients did not experience worsening of their diabetic retinopathy (DR) after initiating semaglutide (Ozempic) to treat their type 2 diabetes (T2D), according to a new study....The rate of eyes that which worsened in DR status after initiating semaglutide increased from 1.3% at 3 months, to 2.2% at 24 months. Among eyes with mild to moderate NPDR, the rates were 2.4% and 3.5% for those time periods, respectively. Conversely, the rate of eyes with severe NPDR or PDR that which improved in disease status after initiating semaglutide increased from 40.0% at 3 months, to 58.7% at 24 months....Among observed complications, more patient eyes with DR were likely to report vitreous hemorrhages at both 3 months (0.15%) and 24 months (0.10%) than they were tractional retinal detachment (0.05% and 0.02%) or neovascular glaucoma (0.04% and 0.04%) at those time points, respectively."

Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety profile of semaglutide in patients with non-alcoholic steatohepatitis: post-hoc analysis of data from two phase 2 studies (CMHC 2023) - P2 | N=391 | NCT02970942 | NCT03987451 | Sponsor: Novo Nordisk A/S | "Data from two phase 2 trials indicate that semaglutide is generally well tolerated in patients with NASH, including those with compensated cirrhosis. No new safety concerns were identified, and the safety profile was similar to that in patients with T2D and overweight/obesity. Data from the ongoing phase 3 trial (NCT04822181) will provide further knowledge about the safety of semaglutide in patients with NASH."

P2 data

Lexaria Bioscience Corp. (NASDAQ: LEXX) Evaluating Proprietary Drug-Delivery Platform for Improved Efficacy of GLP-1 Drugs (GlobeNewswire) - "Lexaria Bioscience Corp...announces its placement in an editorial published by NetworkNewsWire ('NNW'), one of 60+ brands within the Dynamic Brand Portfolio IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community....Lexaria Bioscience Corp...began diabetes-related formal studies last year with its DehydraTECH(TM) platform, which showed reduced blood-sugar levels and lowered body weight. With such encouraging early results, Lexaria is planning to launch new human and animal studies to examine whether DehydraTECH processing can make GLP-1 drugs such as semaglutide even better."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=170 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open

Structures of formulations of GLP-1 receptor agonists #exenatide #lixisenatide #efpeglenatide #liraglutide #semaglutide #dulaglutide #albiglutide.

Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=170 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial

Beyond obesity care: Flood of popular weight loss drugs opens new doors, obstacles in GI (Healio) - '"Previous studies in patients with NASH and stage 2 or 3 fibrosis have shown that semaglutide can improve NASH resolution over 72 weeks. However, there are limited data whether any therapy is effective in patients with NASH cirrhosis,' Rohit Loomba, MD, MHSc..."

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This study used an exposure–response model to predict weight-loss trajectories with #semaglutide using baseline characteristics, A1c, and pharmacokinetic data.

Biora Therapeutics Progresses its BioJet Systemic Oral Delivery PlatformConfirmation of autonomous device function enables progress to testing of pharma collaborators’ molecules (BioSpace) - "Biora Therapeutics, Inc...announced achievement of its device performance targets for the company’s BioJet™ platform for oral...In June, the company presented data generated with the BioJet platform at the American Diabetes Association 83rd Scientific Sessions, assessing the bioavailability of semaglutide delivered via the BioJet device in an animal model. Biora will be presenting more BioJet device-generated data in a short oral discussion at the 59th annual meeting of the European Association for the Study of Diabetes, to be held October 2–6, 2023 in Hamburg, Germany."

Preclinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Umbrella Labs Unveils Semaglutide: A Pioneering Advancement In Health And Wellness (GlobeNewswire) - P=NA | N=NA | "Umbrella Labs...proudly announces the launch of its latest breakthrough product, Semaglutide for sale. This innovative supplement, backed by cutting-edge research, marks a new era in health optimization and metabolic well-being....Umbrella Labs conducted an independent clinical study involving participants representing diverse metabolic profiles....The results were impressive, with participants experiencing significant improvements in fasting blood glucose levels and insulin sensitivity. The study also revealed considerable reductions in body weight and waist circumference among Semaglutide users, showcasing its potential to transform metabolic health and weight management."

Clinical data • Commercial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Allurion Announces Acceptance of Nine Scientific Presentations at IFSO 2023 World Congress (Businesswire) - "Allurion...announced the acceptance of nine scientific presentations at the upcoming 26th World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). These presentations consist of four abstracts that will be presented as oral presentations, four abstracts that will be presented as posters, and one moderated presentation. IFSO takes place in Naples, Italy, from August 30 to September 1."

Clinical data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Clinical Trial Studying Possible New Treatment Option for Patients with NAFLD - '"Liver disease is a silent killer, and most people do not know they have a liver problem until it is advanced to cirrhosis because there are no obvious symptoms,' said Rohit Loomba, MD..."

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S4-E32.5 - From the Vault: ILC 2022 Looking Back: Crystal Balling & The Semaglutide Trial (YouTube) - "Because Stephen Harrison needs to depart, the episode starts with him answering a question about the most consequential paper in the Congress. He focuses on the resmetirom late-breaker, which presages potential drug approval within the next 18 months....From here, the group provides answers to the 'most consequential presentation' question and the conversation comes to an end."

Audio

Effect of semaglutide 2.4 mg on alanine aminotransferase in adolescents with obesity: a post-hoc analysis of the STEP TEENS trial (ECO 2023) - No abstract available.

The use of semaglutide does not improve fibrosis in cirrhosis related to non-alcoholic steatohepatitis [Google translation] (Medscape) - "'Previous studies in patients with nonalcoholic steatohepatitis and stage 2 or 3 fibrosis have shown that semaglutide can improve the resolution of nonalcoholic steatohepatitis within 72 weeks. However, data on the efficacy of treatment in patients with cirrhosis for nonalcoholic steatohepatitis are rare,' lead author Rohit Loomba, MD....'Administration of glucagon-like peptide 1 analogues-in patients with compensated cirrhosis who have morbid obesity and type 2 diabetes-for the treatment of diabetes appears to be well tolerated and may be safe,' said Dr. Loomba."

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No difference between semaglutide, placebo in fibrosis improvement in patients with NASH (Healio) - "'Previous studies in patients with NASH and stage 2 or 3 fibrosis have shown that semaglutide can improve NASH resolution over 72 weeks. However, there are limited data whether any therapy is effective in patients with NASH cirrhosis,' Rohit Loomba, MD, MHSc...told Healio....'Future trials with larger sample sizes will be needed to determine whether semaglutide alone or in combination with other liver-targeted agents will improves outcomes such as liver-related morbidity and mortality in patients with NASH and compensated cirrhosis,' Loomba said."

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A Research Study of a New Medicine NNC0113-6856 in Healthy Males (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Semaglutide Doesn't Improve Fibrosis in NASH-Related Cirrhosis (Medscape) - "'As these patients are oftentimes excluded from initial randomized controlled trials, we have significantly less information on how to address obesity, type 2 diabetes, and NASH in these patients,' Fernando Bril, MD...told Medscape Medical News."

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