With over 42% of Americans grappling with obesity, a condition that often paves the way for diseases like diabetes, the battle against excess weight is a prevalent challenge. Studies have shown that approximately 6 in 10 adults are working towards losing weight, with 28% aiming to lose more than 20 pounds. Achieving a healthy weight can be challenging and require significant effort and dedication. With so many promising weight loss medications available, finding one that suits you can be difficult.

To address this issue, a new drug called VK2735 has recently shown results in clinical trials, which could be effective in weight loss. According to reports, it offers five times faster weight loss than other popular drugs like Ozempic and Wegovy, which have already made a significant impact. However, this medication is not yet available in the market.

In this article, you will learn about this new drug and how it can help you achieve your weight loss goals. We will explore how it works, its effectiveness, and how it compares to other weight loss drugs such as Ozempic and Wegovy injection pens.

Key Takeaways

  • VK2735, a GLP-1/GIP dual agonist, offers a revolutionary approach to weight loss, providing up to five times faster results than existing medications like Ozempic and Wegovy, with participants in a phase 2 trial experiencing up to 14.7% weight loss from their baseline body weight.
  • The drug demonstrates high efficacy in clinical trials. Up to 88% of participants in the VK2735 treatment groups achieved a weight loss of ?10% over 13 weeks, significantly outperforming the placebo group.
  • VK2735 starts to show its weight loss effects from the first week of treatment. It continues progressively over 13 weeks without plateauing, suggesting the potential for further weight loss with extended dosing.
  • By targeting both GLP-1 and GIP receptors, VK2735 promotes significant weight loss, enhances glucose control, and improves insulin sensitivity more effectively than targeting either receptor alone.
  • VK2735 has shown a mean placebo-adjusted body weight reduction of 14.7%, significantly exceeding the efficacy seen with Ozempic and Wegovy in similar duration trials, positioning it as a potentially more effective option for weight management.
  • The most common side effects reported in the phase 2 VENTURE trial were gastrointestinal and considered mild to moderate, making VK2735 manageable in terms of adverse effects.
  • Viking Therapeutics plans to advance VK2735 into phase 3 trials following promising phase 2 results. The company aims for FDA approval in the coming years. This could potentially revolutionize the weight loss industry and offer new hope for individuals struggling with obesity.

Understanding GLP-1 and GIP Dual Agonists

Woman with measuring tape on her belly

GLP-1 (Glucagon-like Peptide-1) and GIP (Glucose-dependent Insulinotropic Polypeptide) are important hormones that help regulate blood sugar levels and satiety. They are key targets in managing obesity and type 2 diabetes mellitus (T2DM). Let’s take a closer look at these hormones and their functions.

GLP-1

GLP-1 is a hormone produced in the gut in response to food intake. It has several important actions that contribute to glucose regulation and appetite control:

  • Enhances Insulin Secretion: GLP-1 stimulates the pancreas to release insulin when blood sugar levels are high, which helps lower blood glucose levels.
  • Slows Gastric Emptying: By slowing down the rate at which the stomach empties its contents into the small intestine, GLP-1 helps reduce the speed of glucose absorption into the bloodstream, leading to a more gradual rise in blood sugar levels after eating.
  • Suppresses Appetite: GLP-1 acts on the brain to promote feelings of fullness and satisfaction, reducing overall food intake.

GIP

GIP, like GLP-1, is an incretin hormone released from the gut after eating. It works with GLP-1 to regulate blood sugar levels but has unique mechanisms:

  • Stimulates Insulin Release: Similar to GLP-1, GIP promotes insulin secretion from the pancreas, but its effectiveness can be diminished in individuals with type 2 diabetes.
  • Influences Fat Storage: GIP has been shown to play a role in lipid metabolism, promoting fat storage in adipose tissue.

Dual GLP-1 and GIP Receptor Agonists

Recent developments in treating obesity and diabetes have created dual agonists that target GLP-1 and GIP receptors. These dual agonists combine the benefits of GLP-1 and GIP receptor activation in a single molecule, offering a potent therapeutic option. By stimulating both receptors, they enhance glucose control, promote significant weight loss, and improve insulin sensitivity more effectively than targeting either receptor alone.

Dual activation results in the following benefits:

  • Enhanced insulin secretion and sensitivity, leading to better control of blood glucose levels.
  • Reduced food intake, delayed gastric emptying, and effects on satiety signals contribute to weight loss.
  • Improved lipid metabolism and reduced fat deposition, further supporting weight management efforts.

Clinical trials have demonstrated the efficacy of these dual agonists in reducing body weight, lowering HbA1c levels (a measure of blood sugar control over time), and improving overall metabolic health in individuals with T2DM and obesity. These outcomes are achieved with fewer adverse effects compared to traditional treatments, making dual agonists a promising option for individuals struggling with the management of obesity and T2DM.

The Breakthrough Study of VK2735

Two scientists working together in a lab

VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors, developed by Viking Therapeutics for potentially treating various metabolic disorders, including obesity. It is currently in clinical development, with positive top-line results announced from a Phase 2 trial (the VENTURE trial) demonstrating its efficacy in significantly reducing body weight in obese patients.

The study involved 176 adult participants who were either obese or overweight with at least one weight-related condition. For 13 weeks, the participants received once-weekly doses of VK2735 at varying strengths or a placebo. The aim was to assess the drug’s impact on body weight and safety.

The study showed that VK2735 effectively reduced body weight across all doses. After 13 weeks, participants showed up to 14.7% weight loss from their baseline body weight, with a placebo-adjusted mean percent weight loss ranging up to 13.1%. This was significantly higher compared to the placebo group. Up to 88% of the participants in the VK2735 treatment groups achieved a weight loss of ≥ 10%, while only 4% in the placebo group achieved the same. The weight loss began from the first week of treatment. It continued progressively over the 13 weeks without plateauing, indicating the potential for further weight loss with extended dosing.

These results are significant because they exceed the effectiveness of other GLP-1 agonists, such as Ozempic and Wegovy, which are already established in the weight management market. The rapid percentage of body weight loss among participants, especially in the 15 mg dosage group, indicates that VK2735 could be a game-changer in the weight management industry. It is a promising development that could help millions of people struggling with weight loss to achieve their goals and improve their overall health and well-being.

Did you know

The US is ranked as the 12th most obese country in the world. It is estimated that slightly over 42% of American adults suffer from obesity, while approximately 30.7% are overweight. As a whole, more than two-thirds of adults in the US are either overweight or obese.

Does VK2735 Have Oral Formulation?

Yes, Viking Therapeutics is developing an oral formulation of VK2735, in addition to the subcutaneous (injected) version that was primarily used in the Phase 2 VENTURE trial for the treatment of obesity. This oral version of VK2735 is intended to offer a more convenient route of administration for patients, potentially increasing adherence and ease of use compared to injections.

The development of an oral formulation represents an advancement in the delivery of treatment for metabolic disorders such as obesity. Patients generally prefer oral formulations for their ease of use and non-invasiveness compared to subcutaneous injections. This can significantly impact the patient’s willingness to start and continue the treatment, which is critical for chronic conditions requiring long-term management.

Viking Therapeutics has mentioned that it remains on track to report data from a Phase 1 study of the oral formulation of VK2735 later in the quarter, indicating ongoing clinical development efforts to evaluate its safety, tolerability, and pharmacokinetics. This move towards an oral version aligns with the broader trend in pharmaceutical development to improve patient experience and outcomes by offering more patient-friendly medication formats.

Comparison with Ozempic and Wegovy

Comparing VK2735 with two established GLP-1 receptor agonists, Ozempic and Wegovy, reveals a significant advancement in weight management. Clinical trial outcomes show that VK2735 performs better than these drugs, which showcases a potential shift in the approach to treating obesity and related conditions.

In the phase 2 VENTURE trial, VK2735 showed an impressive mean placebo-adjusted body weight reduction of 14.7%, surpassing the efficacy of Ozempic and Wegovy. This means that VK2735 is more potent in reducing body weight. However, it is important to note that the VENTURE trial lasted for 13 weeks, while the studies for Ozempic and Wegovy were conducted over longer periods.

Therefore, the comparison must consider the duration of the trials. Ozempic and Wegovy are GLP-1 receptor agonists that contain semaglutide but at different dosages. They have been widely studied for weight loss and diabetes management, and both medications have proven effective in inducing weight loss.

However, Wegovy’s higher maximum dose may offer more substantial weight loss benefits. For instance, a major study showed that patients on Wegovy could expect an average weight loss of about 20% of their body weight over 68 weeks, highlighting its potency in obesity management. On the other hand, Ozempic is primarily used for treating type 2 diabetes but can also cause weight loss in lower doses. It has been observed that Ozempic can lead to a weight loss of around 15% of body weight over 68 weeks.

While all three medications have demonstrated efficacy in weight loss management, VK2735 has shown a higher percentage of body weight loss in a shorter period, making it a potentially more effective option for people struggling with obesity and weight-related comorbidities.

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Buy Canadian Insulin is dedicated to providing resources and information to help you maintain good health. If you want to learn more about Ozempic and Wegovy, you can read some of our articles.

Potential Side Effects and Considerations

A doctor holding side effects inscription

The phase 2 VENTURE trial has reported some common side effects that people may experience while using the drug. Most of these side effects were related to the gastrointestinal system and were considered mild or moderate. Some of the reported side effects are as follows:

  • Nausea: 43% of VK2735-treated patients experience nausea, with the majority being mild (68%) and the rest moderate.
  • Vomiting: Reported by 18% of those on VK2735.
  • Diarrhea: Affecting 20% of VK2735 recipients.
  • Constipation: Experienced by 26% of the VK2735-treated group.
  • Decreased appetite: Reported by 16% of participants receiving VK2735.

When Is VK2735 Expected to be Available in the Market?

Viking Therapeutics has not provided a specific timeline for when the drug will be available on the market.  The process from Phase 2 clinical trials to market release involves several steps, including completing Phase 3 trials, submitting a New Drug Application (NDA) to the FDA, and the FDA’s review and approval process.

Phase 3 trials are larger and designed to confirm the drug’s effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely. Upon successful completion of Phase 3, the company would then submit an NDA to the FDA, which includes all the data from the drug’s development, including clinical trials, for review.

The FDA review process can take several months to over a year, depending on the drug’s priority status and the completeness of the application. Given that Viking Therapeutics plans to progress VK2735 into further clinical development later in the year mentioned in the press release (2024) and considering the typical durations of subsequent phases and regulatory reviews, it may be several years before VK2735 is available on the market.

Various factors could influence the timeline, including the results of future clinical trials, regulatory feedback, and the speed at which the company can compile and submit the necessary documentation for approval.

Final Thoughts

VK2735 is a promising new drug offering a revolutionary weight loss approach, providing up to five times faster results than existing medications like Ozempic and Wegovy. It is important to note that the medication is not yet available in the market, but Viking Therapeutics plans to advance it into phase 3 trials following promising phase 2 results. The potential approval of VK2735 by the FDA could revolutionize the weight loss industry and offer new hope for individuals struggling with obesity.

With its unique mechanism of action and high efficacy, VK2735 could be a game-changer for those who have been unsuccessful in their weight loss journey. However, it is always important to consult with a healthcare provider before starting any new medication in the future. By understanding the benefits and risks of different treatment options, individuals can make informed decisions about their health and achieve their weight loss goals safely and effectively.

FAQs On GLP-1/GIP VK2735 for Weight Loss

Was VK2735 well-tolerated by participants in the trial?

Yes, VK2735 was shown to be safe and well-tolerated. Most treatment-emergent adverse events (TEAEs), especially gastrointestinal-related ones, were mild or moderate in severity.

How was VK2735 administered in the Phase 2 VENTURE trial?

In varying dosages, VK2735 was administered subcutaneously, once weekly, to assess its efficacy and safety.

What were the dosage levels tested in the VENTURE trial?

The trial tested several dosages of VK2735, including 2.5 mg, 5 mg, 10 mg, and 15 mg, to determine the optimal dose for efficacy and safety.

What were the eligibility criteria for participants in the VENTURE trial?

Participants were adults who were obese (BMI ? 30 kg/m^2) or overweight (BMI ? 27 kg/m^2) with at least one weight-related comorbid condition.

Sources

Viking Therapeutics. (2024, February 27). Viking Therapeutics Announces Positive Top-Line Results from Phase 2 VENTURE Trial of Dual GLP-1/GIP Receptor Agonist VK2735 in Patients with Obesity [Press release]. PR Newswire. https://ir.vikingtherapeutics.com/2024-02-27-Viking-Therapeutics-Announces-Positive-Top-Line-Results-from-Phase-2-VENTURE-Trial-of-Dual-GLP-1-GIP-Receptor-Agonist-VK2735-in-Patients-with-Obesity

Kaiser Family Foundation. (2023, August 4). KFF Health Tracking Poll July 2023: The Public’s Views Of New Prescription Weight Loss Drugs And Prescription Drug Costs. https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-july-2023-the-publics-views-of-new-prescription-weight-loss-drugs-and-prescription-drug-costs/

Zaffina, I., Armentaro, G., Giofrè, F., Cassano, V., Sciacqua, A., Arturi, F., & Pelle, M. C. (2023). Effect of dual glucose-dependent insulinotropic peptide/glucagon-like peptide-1 receptor agonist on weight loss in subjects with obesity. Frontiers in Endocrinology, PMC9992880. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9992880/

Novo Nordisk. (2024, January). 68-Week Trial Results | Wegovy® (semaglutide) injection 2.4 mg. NovoMedLink. https://www.novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/clinical-trial-1-results.html

Cleveland Clinic. (2023, March 29). Should You Take Ozempic for Weight Loss? [Webpage]. Retrieved from https://health.clevelandclinic.org/ozempic-for-weight-loss