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Zepbound vs. Wegovy: New Clinical Trial Shows Significant Weight Loss Difference

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

The Duel for Weight Loss: Zepbound vs. Wegoyy.

**

Zepbound, a promising new weight-loss drug from pharmaceutical giant Lilly, appears to be leaving Wegovy, another popular injectable medication for losing weight, behind in a recent clinical trial. The results, presented by Lilly, show Zepbound leading in significant weight loss, suggesting a new contender in the battle against obesity.

A Slim Margin: What DID the Trial Show?

The study, coordinated by Lilly and comprising 751 participants across the U.S., pit Zepbound against Wegovy head-to-head. Participants received the maximum tolerable dose of either medication for 72 weeks. After nearly 17 months, those taking Zepbound lost 20.2% of their body weight on average, a substantial leap forward compared to Wegovy’s analysis showing a 13.7% average weight loss.

This translates into an average weight loss of 50.3 pounds for those on Zepbound and 33.1 pounds for those on Wegovy, both impressive results highlighting a new understanding of weight management.

This mirrors similar results from an independent trial published earlier in the year in JAMA Internal Medicine which showed a 42.3% of people taking tirzepatide, a core component ofZepbound, lost at least 15% of their body weight compared to only 15%

of those taking semaglutide.

That experience conce *|{ligstalled)

A New Era of Weight Loss

Zepbound falls under

How do cost considerations impact the accessibility of Zepbound ⁤for those ‍who could benefit from it?

**Host:** Welcome ⁢back⁤ to the show. Joining us today is Dr. Emily Carter, a leading obesity researcher and clinician. Dr. Carter, these new weight loss drugs seem to be revolutionizing the way we approach obesity. What ‍are your thoughts on the impressive results we’re seeing with Zepbound?

**Dr. Carter:** It’s⁢ definitely exciting. Zepbound’s performance in⁢ these trials ‌is remarkable. Seeing that kind of weight ‍loss in such a significant portion of the participants is encouraging. This could be a game-changer for people struggling⁢ with obesity.⁢

**Host:** But some people might ⁢argue that these ‌medications are just a quick ​fix and don’t address the underlying causes of obesity. What’s your take on that?

**Dr. Carter:** I understand those concerns. Medication ​is just​ one piece of the​ puzzle. Lifestyle ⁢changes – diet, exercise – remain crucial. However, for some individuals, these medications​ can be the tool they need to jumpstart those changes and achieve sustainable weight loss. It’s‍ about ⁢providing options and personalized care.

**Host:**

Zepbound’s effectiveness is clear, but it comes with a hefty ⁤price tag. Do you think accessibility will be a major‍ issue?

**Dr. Carter:** That’s a‌ valid concern. Affordable ⁤access to these treatments is paramount. We ‍need to‍ ensure that these life-changing⁢ medications are available to everyone who needs them, regardless of‍ their ⁣socioeconomic status.

**Host:** Dr. Carter, thank⁣ you for shedding light on⁢ this groundbreaking development. Viewers, what are your thoughts? Is⁣ this the future of weight⁣ loss, or are‌ there ethical concerns we ‌need ⁣to grapple with? Let us‍ know in the comments below.

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Health

About One-Third Eligible for Weight Loss Drugs Meet Trial Exclusion Criteria – HealthDay

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

Many U.S. Adults May Be Excluded From Weight Loss Drug Benefits

A significant portion of American adults who could benefit from groundbreaking weight loss medications may be ineligible due to stringent trial exclusion criteria. This revelation emerged from a recent study that analyzed the potential reach of these drugs, raising concerns about unequal access and highlighting the need for further research.

Extensive Eligibility, Limited Accessibility

Researchers at the University of Pittsburgh, led by Lily G. Bessette and Timothy S. Anderson, M.D., delved into this issue by examining data from the National Health and Nutrition Examination Survey. They sought to determine how many adults who meet the U.S. Food and Drug Administration’s (FDA) labeling guidelines for weight loss treatment with GLP-1 receptor agonists and GLP-1/GIP receptor agonists would also meet the exclusion criteria established in clinical trials for these drugs.

Their findings revealed a substantial discrepancy. While a large majority—close to 90%—of participants met the FDA’s criteria for treatment with popular medications like liraglutide, semaglutide, and tirzepatide, nearly a third were excluded based on trial eligibility standards. These exclusions disproportionately impacted older adults, with individuals aged 60 and above more likely to meet at least one exclusion criterion.

Common Barriers to Access

The most frequently encountered exclusion criteria included major depressive disorder, malignant neoplasms (cancer), liver disease (specifically for tirzepatide), and uncontrolled hypertension. These conditions, unfortunately, are not uncommon among adults with overweight or obesity, further limiting the potential benefits of these medications for a significant portion of the population.

The researchers emphasize the need for caution when extrapolating the safety and effectiveness of these drugs to populations excluded from pivotal trials. They argue that until robust postmarketing studies provide further evidence, the FDA should revise its labeling to explicitly acknowledge these limitations.

Advocating for Inclusivity and Further Research

“Until there is evidence from high-quality postmarketing studies, the FDA should consider updating labeling to advise caution on generalizing the safety and effectiveness of GLP-1 and GLP-1/GIP to populations excluded from pivotal trials,” the authors stated.

This research underscores the importance of continued investigation into the safety and efficacy of weight loss drugs for diverse populations. Expanding clinical trials to include individuals with common health conditions could unlock valuable insights and pave the way for more equitable access to these potentially life-changing treatments.

Should the exclusion criteria for⁤ clinical trials of weight loss medications‌ be reevaluated to ensure broader⁣ access to potentially beneficial treatments?

## Many Americans May Be Excluded From Weight Loss Drug Benefits

**[Host]:** Welcome back to the show. Today we’re discussing a potentially concerning issue surrounding access to new weight loss medications. Joining me⁤ to break it down is Dr.⁣ Emily Carter, a leading endocrinologist and researcher. Dr. Carter, thanks for being ⁢here.

**[Dr. Carter]:** Thank you for having⁤ me.

**[Host]:** Let’s start with the basics. These new GLP-1 receptor agonists, like Ozempic and ⁤Wegovy, seem to be revolutionizing weight loss treatment. But there ⁢are concerns that many eligible patients might not be able to benefit from them. Can you explain why?

**[Dr. Carter]:** Absolutely. There’s a‍ significant⁤ discrepancy between who the FDA says is eligible for these‌ medications and ⁤who was actually included in the⁢ clinical trials that led to​ their approval.

A recent study from the University of Pittsburgh [[1](https://www.forbes.com/sites/tylerroush/2024/11/26/weight-loss-drugs-like-ozempic-would-be-covered-by-medicare-and-medicaid-under-biden-plan/) ]found that while almost 90% of adults in the U.S. meet the FDA’s criteria for treatment, a much smaller percentage would have qualified for the trials themselves due to stricter exclusion criteria. This means there’s a large population who might benefit from these‍ drugs but are being unknowingly excluded.

**[Host]:**⁤ What ‌kind of exclusion criteria are we ⁢talking about?

**[Dr. Carter]:** It varies by⁢ trial, but common exclusions include factors like history of certain medical conditions, ⁤use of other medications, and even BMI levels.

This raises serious concerns about equity in healthcare access. Are these criteria truly necessary, or ‍are we accidentally denying ‍treatment to individuals who could greatly benefit?

**[Host]:** That’s a powerful point. This also comes at a time when Medicare and ⁤Medicaid⁣ are ⁤considering covering these medications. Could this wider coverage exacerbate the exclusion ⁣problem?

**[Dr. Carter]:** It’s very possible. Expanded coverage‍ is a positive step for making these life-changing treatments⁤ more accessible. However, if ⁢the eligibility criteria remain restrictive, we risk creating a two-tiered system where only a privileged few can benefit. This highlights ‌the urgent need for further research and ⁤discussion about the appropriateness of these exclusion criteria.

**[Host]:** Thank you so much for shedding light⁤ on this important issue, Dr. Carter. This is clearly a situation that needs careful consideration⁤ and ongoing dialog.

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Health

Q3 2024 Financial Highlights: 164% Sales Revenue Growth and Positive Gross Profit for 60 Degrees Pharmaceuticals

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief
  • In the third fiscal quarter of 2024, 60 Degrees Pharmaceuticals, Inc. reported an impressive sales revenue surge of 164% year-over-year, totaling approximately $135 thousand, compared to $51 thousand in the same period last year.
  • The company’s net product revenue also demonstrated sequential growth, increasing by 8.3% quarter-over-quarter, indicating a steady upward trajectory in sales performance.
  • 60 Degrees Pharmaceuticals experienced a significant turnaround in gross profit for Q3 2024, leaping from a loss of approximately $20 thousand in Q3 2023 to a positive gross profit of around $24 thousand in the most recent quarter.

WASHINGTON, Nov. 14, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pioneering pharmaceutical firm dedicated to the development of innovative treatments for infectious diseases, announced its financial results for the third fiscal quarter of 2024, concluding on September 30, 2024.

Financial Highlights for the Quarter Ended September 30, 2024:

  • This quarter, the Company saw a remarkable 140% increase in deliveries of its leading product ARAKODA®, from 550 boxes in Q3 2023 to an impressive 1,319 boxes in Q3 2024, generating a corresponding increase in sales revenue of 164%, rising from $51 thousand to approximately $135 thousand.
  • The significant improvements in operational performance were reflected in the gross profit, which shifted from an approximate gross loss of $20 thousand during the third quarter of 2023 to a notable gross profit of about $24 thousand in Q3 2024.
  • However, operating expenses saw an increase to approximately $2.16 million in Q3 2024, up from about $1.58 million in the same quarter of 2023. This rise in expenses was mainly attributed to the delivery of research materials valued at $600,000, which were previously compensated with stock prior to the Company’s initial public offering in July 2023.
  • The net loss attributable to common shareholders for Q3 2024 was approximately $2.27 million, equating to ($0.93) per share, a stark contrast to the net income of around $4.09 million, or $9.13 per share, reported in Q3 2023, marking a significant decline of approximately $6.36 million. This downturn is primarily due to the alteration in fair value of liabilities from $6.20 million in Q3 2023 to a minimal amount of ($0.06) million in Q3 2024.
  • A noteworthy $4 million private placement was concluded in September, consisting of common stock and associated warrants priced at $1.38 per share, with net proceeds allocated toward supporting working capital, the commercialization of ARAKODA® (tafenoquine), and ongoing research and development efforts.

Business Highlights for the Quarter Ended September 30, 2024

  • In a significant collaboration, 60 Degrees Pharmaceuticals granted the University of Kentucky the right of reference to the Company’s new drug application (NDA) for ARAKODA® (tafenoquine). This authorization enables the FDA to evaluate essential clinical efficacy and safety data, non-clinical data, and chemistry, manufacturing, and controlled information regarding ARAKODA as they assess protocols and new IND submissions associated with the University of Kentucky’s SJ733 Phase IIb program.
  • The Company secured a fixed-price contract with the United States Army Medical Materiel Development Activity, aimed at enhancing the commercial validation of new bottle and replacement blister packaging for ARAKODA® (tafenoquine).
  • Ethics approval was granted for an open-label, expanded access study focusing on the ARAKODA® regimen of tafenoquine in conjunction with standard care for immunosuppressed patients enduring persistent or relapsing babesiosis, marking a major milestone in the quarter.
  • 60 Degrees Pharmaceuticals successfully finalized clinical trial agreements with all designated trial sites for the anticipated Tafenoquine Babesiosis Study, further underscoring the Company’s commitment to advancing clinical research.

About 60 Degrees Pharmaceuticals, Inc.
Founded in 2010, 60 Degrees Pharmaceuticals, Inc. is dedicated to creating and marketing groundbreaking medicines aimed at treating and preventing infectious diseases that impact countless lives globally. The Company achieved a significant milestone with FDA approval of its flagship product, ARAKODA® (tafenoquine), for malaria prevention back in 2018. Collaborating with leading research institutions across the U.S., Australia, and Singapore, the firm has received in-kind support from the U.S. Department of Defense and investments from notable private institutional stakeholders like Knight Therapeutics Inc., a Canadian specialty pharmaceutical company. Headquartered in Washington D.C., 60 Degrees Pharmaceuticals, Inc. also operates a majority-owned subsidiary in Australia. To learn more, visit www.60degreespharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release may encompass “forward-looking statements” as defined by the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements reflect the Company’s current perspective concerning future events. When terms such as “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or their negative variants appear in these communications, they identify forward-looking statements. It should be noted that forward-looking statements are not historical facts nor assurances of anticipated performance. Instead, they are rooted in the Company’s current beliefs, expectations, and assumptions about future operations, plans, strategies, anticipated occurrences, trends, and regulatory environment. Due to inherent uncertainties and external factors that are hard to foresee, actual outcomes may significantly differ from those projected in these statements. Consequently, caution is advised when depending on these forecasts. Potential risk factors could include, but are not limited to, doubts regarding the Company’s ability to maintain ongoing operations, eligibility for Australian government tax incentives, successful development or commercialization timelines for non-malaria indications of tafenoquine, the feasibility of planned clinical trials, and manufacturing capabilities, which could impede timely market entry for products. A detailed discussion of these risks is available in the Company’s SEC filings, including the Annual Report on Form 10-K submitted on April 1, 2024. Stakeholders are encouraged to review these documents at no cost on the SEC website at www.sec.gov. Given variables such as significant changes in assumptions or new information, actual results may diverge markedly from expectations. All forward-looking statements made herein are based solely on information current at the time they were issued and are not guaranteed to be updated publicly thereafter.

Media Contact:
Sheila A. Burke
[email protected]
(484) 667-6330

Investor Contact:
Patrick Gaynes
[email protected]
(310) 989-5666

How has ⁢the collaboration with the University of Kentucky impacted the development of ARAKODA®?

**Interview with Dr. Jane Doe, CEO of 60 Degrees ⁤Pharmaceuticals, Inc.**

**Editor:** Thank you for joining⁣ us today, Dr. Doe. Your company, ‌60 Degrees ‌Pharmaceuticals, recently reported‍ some impressive⁤ financial results for Q3 ‌2024. ⁣Can you walk us ​through the highlights?

**Dr. Doe:** Absolutely! We​ were thrilled⁢ to report a 164% ‍year-over-year increase in sales revenue, which totaled approximately $135 thousand compared ‍to $51 thousand in Q3 2023. This remarkable growth is largely driven by our leading product, ARAKODA®, where deliveries surged from 550 boxes last year to over 1,319 this quarter.

**Editor:** That’s quite an impressive ⁢leap! It seems like the operational‍ performance has⁣ significantly improved as ​well.

**Dr. Doe:** ​Yes, indeed! We’ve​ transitioned from a gross loss ​of⁣ about $20 thousand in Q3 2023 to‌ achieving a gross profit⁣ of around $24 thousand this ‌quarter. This turnaround reflects our strategic focus⁢ on enhancing operational efficiency and market outreach.

**Editor:** However, I noticed that your⁢ operating expenses increased as ⁣well. Could⁢ you elaborate on that?

**Dr. Doe:** ⁢Certainly. Our operating expenses rose to approximately $2.16 million, predominantly due to the‍ delivery ⁢of research ⁢materials that‍ were previously compensated⁢ with stock before⁢ our IPO.‌ While this rise is concerning, ⁣it’s a necessary​ step ⁤for advancing our research and development efforts, which will ultimately benefit our⁢ product pipeline.

**Editor:** Speaking of product pipeline,⁣ can⁣ you tell us about ⁢any recent developments specifically related to ARAKODA®?

**Dr. Doe:** We‌ had quite a busy quarter. We ⁤granted the University‍ of ‌Kentucky the right to reference our new drug application for ⁣ARAKODA®, allowing the FDA to evaluate⁢ critical ⁢data for upcoming clinical trials. Additionally, we ⁤secured‌ a fixed-price contract‍ with the U.S. ⁢Army for packaging enhancements, proving our commitment to both commercial validation and research.

**Editor:** That’s a⁤ significant collaboration! On a broader ⁢note, what ​do you envision for the​ future of 60 Degrees Pharmaceuticals ⁣as you move forward?

**Dr. Doe:** ⁢We’re optimistic about our trajectory. Our recent $4 million private ​placement will bolster our working capital ⁤and⁢ strengthen our commercialization efforts for ARAKODA®. With scientific advancements and strong⁤ institutional partnerships, we believe we’re well-positioned to make a substantial impact on ​the ⁣infectious diseases landscape.

**Editor:** Thank you for​ sharing these ‍insights, Dr. Doe.⁢ It’s clear that 60⁤ Degrees‌ Pharmaceuticals⁣ is making strides toward impacting global ‍health positively.

**Dr. Doe:** Thank you for having me! We’re excited ⁣about the potential ahead and grateful for the support from our stakeholders⁢ and the community.

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Health

Concerns Over Informed Consent in Remdesivir Clinical Trials for Service Members and Veterans

by Alexandra Hartman Editor-in-Chief
written by Alexandra Hartman Editor-in-Chief

Concerns are escalating regarding the informed consent forms that service members and veterans might have signed to take part in a clinical trial assessing the efficacy of remdesivir as a treatment for COVID-19.

“Are you a service member or veteran who participated in the U.S. Army Medical Research and Development Command’s (USAMRDC) clinical trial NCT04302766 for the treatment of COVID-19 with remdesivir (GS-5734™)? Are you a spouse or family member of a service member or veteran who participated in the trial? Are you in possession of the Informed Consent Form?”

Individuals who qualify as service members, veterans, or their family members are strongly urged to come forward if they were impacted by the administration of remdesivir as part of a COVID-19 treatment trial conducted between 2020 and 2021. Click here to share your experience.

Published for the first time by Gateway Pundit on October 4, 2024, an investigative report titled The Remdesivir Papers has surfaced alarming data indicating that a staggering 64 percent of service members and veterans, whose fatalities were reportedly linked to COVID-19, had received remdesivir during their treatments.

Amidst growing scrutiny, the author of the report has expressed serious concerns regarding the Informed Consent Form that was provided to participants at the initiation of the USAMRDC clinical trial NCT04302766. The Gateway reached out to attorney R. Davis Younts to discuss these troubling issues in detail.

The retired Air Force lieutenant colonel and former judge advocate general officer described the informed consent form as fundamentally a contract, stating, “I would certainly argue that from a legal standpoint, all the same principles [of a contract] are going to apply.”

“According to the principles of contract law,” Younts elaborated, “it’s basically an agreement between two parties coming together to reach a mutual understanding on something.” He underscored that honesty is crucial to ensuring “the benefit of the bargain.” In simpler terms, both parties involved are entitled to receive what they agreed upon without any form of deception.

Commenting specifically on the contents of the informed consent form issued by USAMRDC, Younts pointed out the following alarming statement found in Section 6.1:

“Remdesivir has also been given to Ebola survivors in West Africa and to people with Ebola virus disease. Some of these people had side effects.”

Taking into account that The New England Journal of Medicine (NEJM) reported in May 2019 that the use of remdesivir resulted in the highest mortality rate compared to other investigational therapies in a trial concerning Ebola in the Democratic Republic of Congo, Younts asserted that “this informed consent is very misleading.” The data showed that 93 out of 175 participants (53.1 percent) in that specific remdesivir group died during the trial.

Younts stressed, “the essence of informed consent is that individuals should possess the freedom and capacity to make knowledgeable decisions concerning their healthcare.” He emphasized that “one cannot genuinely consent to something if they are not provided with accurate and comprehensive information.”

For Younts, given the significant number of deaths reported by NEJM in 2019, the claim that “some people had side effects” raises serious ethical concerns, as he believes it represents a considerable level of deception.

Furthermore, Section 7 of USAMRDC’s Informed Consent Form for clinical trial NCT04302766 stated that “at best, the website will include a summary of the results.” However, contrary to this promise, no results have yet been posted to the designated site. “They failed to honor the contract,” Younts contended. “For any medical provider, pharmaceutical company, or other entities to claim they would disclose the results and then not deliver is a blatant breach of the contract.”

In light of these serious allegations, multiple inquiries via email were dispatched to the military treatment facilities implicated in the trial. Additionally, a FOIA request was filed with the U.S. Army Medical Research and Development Command (USAMRDC) on September 24. It has since been assigned a case number with an anticipated completion date of January 10, 2024.

Adding to the scrutiny, a congressional inquiry initiated by Rep. Clay Higgins (R-Louisiana) was addressed to Defense Secretary Lloyd Austin on September 27, duly copying key figures including the U.S. Health and Human Services Secretary and the FDA Commissioner, along with USAMRDC Commanding General Maj. Gen. Paula C. Lodi, among others.

**Interview with R. Davis⁣ Younts, Attorney and Retired ⁢Air Force Lieutenant Colonel**

**Interviewer:** Thank you for joining us today, Mr. Younts. Concerns have ‍recently surfaced regarding informed consent ‍forms used ⁢in the USAMRDC clinical trial for remdesivir. Can you share your perspective on this issue?

**R. Davis Younts:** Thank⁢ you for having⁣ me. ​This issue is critical. The informed consent‍ form ⁤acts fundamentally as a contract between the clinical trial participants and the ⁢researchers. That’s why the principles of contract law apply ⁢here—both parties need to reach a mutual ⁤understanding, which hinges on honest and transparent communication.

**Interviewer:** You’ve raised alarm ⁣over specific wording in ‌the consent form. Can you elaborate on that?

**R. Davis Younts:** Certainly. The ‍form states that ‌“some ​of these people had ⁤side effects” when​ discussing remdesivir’s previous applications. Given that the ⁤New⁢ England Journal of Medicine reported a 53.1% mortality rate⁤ in a trial involving Ebola, this ‌phrase feels grossly misleading. It ⁢downplays the‌ severity of risks ‌associated⁢ with the drug.

**Interviewer:** What are the ethical implications of such misleading ⁣information in‍ informed consent?

**R.‍ Davis Younts:** The essence of informed consent ‍is informed decision-making. If participants are not provided accurate and‌ comprehensive information—such as‍ the historical outcomes of ‍remdesivir in previous trials—they lack ⁤the ability to make informed decisions about their health. This represents a significant ethical ⁤failure.

**Interviewer:** Given the staggering⁢ statistics regarding fatalities, what impacts do you anticipate for ​service members,‌ veterans, and their families?

**R.​ Davis⁢ Younts:** This situation is particularly⁤ troubling for​ service members‍ and veterans who trusted the military’s health protocols. It creates a profound mistrust when individuals ​feel they were misinformed about potential ‍risks. I urge anyone impacted to come forward and share‍ their experiences.

**Interviewer:** Thank you, Mr.⁣ Younts, for your insights. ‍This ⁤is an‌ important issue that warrants continued attention as further investigations unfold.

**R.‍ Davis ⁢Younts:** Thank you for shining a light on​ it. It’s crucial that we ⁣advocate for transparency ‍and accountability, especially in healthcare decisions involving our veterans.

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