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PLAINSBORO, N.J., March 15, 2021 /PRNewswire/ — Novo Nordisk today announced that results from three trials from the pivotal STEP (Semaglutide Treatment Effect in People with obesity) phase 3 clinical development program with investigational once-weekly subcutaneous semaglutide 2.4 mg will be shared at the virtual ENDO Annual Meeting on March 20-23.

STEP is one of the largest clinical trial programs for the management of obesity, consisting of four global trials involving approximately 4,500 adults with excess weight or obesity. The program provides a detailed snapshot of weight management and lifestyle intervention in participants treated with semaglutide 2.4 mg.¹

“Obesity is a disease that has a direct impact on overall health and may be linked to at least 60 other serious health conditions,” said Anne Phillips, senior vice president, Clinical, Medical and Regulatory Affairs of Novo Nordisk. “Through the comprehensive approach of the core STEP trials, we believe the findings have the potential to help people lose weight and impact medical management for those living with obesity. The strength of the data enabled us to file for FDA approval in December, and we anticipate their decision in the coming months.”

The following will be presented at ENDO:

• STEP 1: Efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg in adults with overweight or obesity (Abstract 6923)
• STEP 1 Exploratory Analysis: Impact of semaglutide 2.4 mg once weekly on body composition in adults with overweight or obesity (Abstract 7180)
• STEP 2: Efficacy and safety of semaglutide 2.4 mg once weekly in adults with overweight or obesity and type 2 diabetes (Abstract 7068)
• STEP 4: Weight maintenance with once-weekly semaglutide 2.4 mg in adults with overweight or obesity reaching maintenance dose (Oral presentation, session ORO2)

In addition to evaluating the effect of weight loss and management, the confirmatory secondary analyses investigated waist circumference and certain cardiometabolic risk factors.^2,3,4,5

Data will be available online from March 20-23 as part of the virtual ENDO annual meeting. Results from the STEP 4 trial will be presented live from 2:00-3:00 PM on March 23.

About semaglutide 2.4 mg for weight management

Once-weekly sc semaglutide 2.4 mg is being investigated by Novo Nordisk as a potential treatment option for obesity. Semaglutide is an analogue of the human glucagon-like peptide-1 (GLP-1) hormone.^6,7

About the STEP clinical trial program  
STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3 clinical development program with once-weekly sc semaglutide 2.4 mg in obesity. The global phase 3a program consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity.¹

About obesity

Obesity is a chronic, progressive and misunderstood disease that requires long-term medical management.^8,9 One key misunderstanding is that this is a disease of willpower, when in fact there is underlying biology that prevents people from losing weight and keeping it off.¹⁰ Obesity is influenced by a variety of factors, including genetics, appetite signals, behavior and the environment.¹⁰ It is a gateway disease and is associated with at least 60 other health conditions.¹¹ The current COVID-19 pandemic has highlighted that obesity also increases the risk for severe illness and hospitalization due to COVID-19.^12,13

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the United States, more than 42% of adults live with obesity.¹⁴

About Novo Nordisk 
Novo Nordisk is a global healthcare company that’s been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.

References

¹ Kushner RF, Calanna S, Davies M, et al. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity. 2020; 28:1050-1061.
² Wilding JP, Batterham R, et al. Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine. February 10, 2021. 
³ Wilding JP, Batterham R, et al. Impact of semaglutide on body composition in adults with overweight or obesity: Exploratory analysis of the STEP 1 study. Presented at ENDO Annual Meeting. March 20-23, 2021. 
⁴ Davies M, Færch L, et al. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes Presented at ENDO Annual Meeting. March 20-23, 2021.
⁵ Domenica R, Abrahamsson N, et al. Weight loss maintenance with once-weekly semaglutide 2.4 mg in adults with overweight or obesity reaching maintenance dose. Presented at ENDO Annual Meeting. March 20-23, 2021
⁶ Blundell J, Finlayson G, Axelsen M, et al. Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Diabetes Obes  Metab. 2017; 19:1242-1251.
⁷ Lau J, Bloch P, Schaffer L, et al. Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. J Med Chem. 2015; 58:7370-7380.
⁸ American Medical Association. A.M.A Adopts New Policies on Second Day of Voting at Annual Meeting. Obesity as a Disease. Available at: http://news.cision.com/american-medical-association/r/ama-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649. Last accessed: February 2021.
⁹ Bray GA, Kim KK, Wilding JPH. World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. ObesRev. 2017;18(7):715-723. doi:10.1111/obr.12551.
¹⁰ Wright SM, Aronne LJ. Causes of obesity. Abdom Imaging. 2012;37(5):730-732.
¹¹ Bays HE, McCarthy W, Christensen S, et al. Obesity Algorithm, presented by the Obesity Medicine Association. Available at: https://obesitymedicine.org/obesity-algorithm/. Last Accessed: February 2021.
¹² Finer N, Garnett SP and Bruun JM. COVID-19 and obesity. Clin Obes. 2020; 10:e12365.
¹³ Ryan DH, Ravussin E and Heymsfield S. COVID 19 and the Patient with Obesity – The Editors Speak Out. Obesity (Silver Spring). 2020; 28:847.
¹⁴ Adult Obesity Facts. Centers for Disease Control and Prevention. https://www.cdc.gov/obesity/data/adult.html. Updated June 29, 2020. Last accessed: February 2021.

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SOURCE Novo Nordisk

RIO DE JANEIRO, March 15, 2021 /PRNewswire/ — Vinci Partners Investments Ltd. (NASDAQ: VINP) (“Vinci Partners, “the Company,” “we,” “us,” or “our”), the controlling company of a leading alternative investment platform in Brazil, announced the closing of R$256 million in commitments for “Vinci Infraestrutura Água e Saneamento Fundo de Participações em Infraestrutura”, or “VIAS”, a fund managed by the Vinci Partners Infrastructure segment.  

This capital raise marks the beginning of a new strategy in Vinci Partners’ Infrastructure segment, focused on investing private capital into the privatization of state-owned companies that provide water and sewage services for the Brazilian population, for which we expect to raise up to R$1.0 billion.

José Guilherme Souza, partner and Head of Infrastructure for Vinci Partners, said, “We are very pleased with our first capital raise for VIAS, as it sets the start for a new investment strategy within the Infrastructure segment. We are seeing a robust pipeline of opportunities, aligned with the sector’s new regulatory framework, which set universal goals of coverage and quality for water and sewage services rendered in Brazil. The Brazilian landscape is currently dominated by state-owned companies, with a relevant privatization and public services concessions agenda from the government, and very few private players with proven track record in the field that are able to invest in all these opportunities.”

About Vinci Partners Infrastructure

Our infrastructure core plus strategy has exposure to real assets related to physical infrastructure, through investments in equity and debt instruments across several sectors, including but not limited to power generation and transmission, transportation and logistics and water & sewage. The infrastructure team seeks control or control-oriented positions and employs active hands-on management of assets and operations. We primarily review brownfield and consolidation opportunities, targeting fragmented industries within sub-strategies.

About Vinci Partners

Vinci Partners is a leading alternative investment platform in Brazil, established in 2009. Vinci Partners’ business segments include private equity, public equities, real estate, credit, infrastructure, hedge funds, and investment products and solutions, each managed by dedicated investment teams with an independent investment committee and decision-making process. We also have a financial advisory business, focusing mostly on pre-initial public offering, or pre-IPO, and merger and acquisition, or M&A, advisory services for Brazilian middle-market companies.

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USA Media Contact

Nick Lamplough / Kate Thompson / Katie Villany
Joele Frank, Wilkinson Brimmer Katcher
+1 (212) 355-4449

Brazil Media Contact
Danthi Comunicações
Carla Azevedo ([email protected])
+55 (21) 3114-0779

Investor Contact

[email protected]

NY: +1 (646) 559-8040
RJ: +55 (21) 2159-6240

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SOURCE Vinci Partners

FORT LEE, N.J., March 15, 2021 /PRNewswire/ — Creatd, Inc. (Nasdaq CM: CRTD) (“Creatd” or the “Company”), the parent company of Vocal, announced the selected winners of Vocal’s “Little Black Book” Challenge, launched in partnership with Moleskine, the legendary brand whose notebooks help the creative community draw inspiration and cultivate their talents.

The Challenge prompted Vocal creators to submit a fictional story imagining what they would do if they came into $20,000 unexpectedly; qualifying stories also included a reference to a “little black book,” a nod to Moleskine’s iconic notebook. This Challenge featured Vocal’s largest reward offered to date, a $20,000 cash prize for the grand prize winner. Additionally, Moleskine rewarded winners with an assortment of Moleskine tools, including writing kits and Smart Notebooks, which enable writers to make space for new stories and concepts while connecting their handwriting to the digital world.

Commented Moleskine CEO Daniela Riccardi, “As a provider of physical spaces where creativity, ingenuity, and self-expression nestle, Moleskine is excited to join Vocal on their like-minded mission to be a platform for talent and connect a worldwide community of passionate creators. Moleskine believes in empowering creativity and knowledge around the world, and sees this partnership as being the first in a series of collaborations that will spark the curiosity and genius of creators at Vocal.” 

Vocal Challenges have a unique ability to capture the hearts and minds of the creative community and drive meaningful engagement. Challenges combine thought-provoking story prompts and sizable reward potential, which work to inspire creators and drive them toward participation. Brands can similarly capitalize on this combined effect by collaborating with Vocal on a sponsored Challenge, prompting the creation of high-quality stories that are centered around the brand’s mission and further disseminated through creators’ respective social channels and promotional outlets.

In total, the “Little Black Book” Challenge generated 12,488 stories, each with a tie-in to the Moleskine brand. Promotional efforts for Challenge submissions garnered over 74 million impressions from over 15 million unique viewers. To view the winners of the “Little Black Book” Challenge, please visit: https://vocal.media/resources/little-black-book-challenge-winners

Commented Erica Wagner, writer, editor, lecturer, and “Little Black Book” Challenge judge: “Choosing the winner of this Challenge was a challenge in itself—and not only because there were over 12,000 entries. The quality of the writing and the storytelling was extremely high; it was a real pleasure to read the submitted stories, and exciting to choose our winners and runners-up.”

Added Creatd COO Laurie Weisberg, “Our partnership with Moleskine had the highest impact of any Vocal Challenge launched to date; we saw participation from nearly half of the highly active and engaged Vocal+ community. We are thrilled with the results and excited at the prospect of continued collaboration with Moleskine, who we see as the ideal partner for Vocal and perfectly aligned with our core value of championing creators and celebrating the written word.”

About Creatd

Creatd, Inc. (Nasdaq CM: CRTD), the parent company of wholly-owned subsidiaries Vocal Ventures, LLC and Creatd Partners, LLC, empowers creators, brands, and entrepreneurs through technology and partnership. Its flagship product, Vocal, is a best-in-class creator platform. For more information, please visit:

Creatd: https://creatd.com;

Creatd Investor Relations: https://investors.creatd.com;

Vocal: https://vocal.media;

Investor Relations Contact: [email protected]

About Moleskine

Moleskine was created as a brand in 1997, born from the heritage of a legendary notebook used by artists and thinkers of the past two centuries. Today, Moleskine offers a vast family of notebooks, journals, bags, smart notebooks that connect our paper to screen, apps, and writing tools. Together, they form an ecosystem of tools and services which inspires imaginations, exploration, and fuels creative practice. For more information, please visit https://us.moleskine.com.

Forward-Looking Statements

Any statements that are not historical facts and that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, indicated through the use of words or phrases such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “intends,” “plans,” “believes” and “projects”) may be forward-looking and may involve estimates and uncertainties which could cause actual results to differ materially from those expressed in the forward-looking statements. We caution that the factors described herein could cause actual results to differ materially from those expressed in any forward-looking statements we make and that investors should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which such statement is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of anticipated or unanticipated events or circumstances. New factors emerge from time to time, and it is not possible for us to predict all of such factors. Further, we cannot assess the impact of each such factor on our results of operations or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. This press release is qualified in its entirety by the cautionary statements and risk factor disclosure contained in our Securities and Exchange Commission filings.

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SOURCE Creatd, Inc.