FDA APPROVED TIRZEPATIDE/MOUNJARO FOR WEIGHT LOSS! WOODSTOCK /ATLANTA GA

07 Dec 23

As of November 2023 the FDA has approved the use of tirzepatide/mounjaro for both type 2 diabetes and now WEIGHT LOSS due to obesity. This is exciting news!

Find out in this blog post how this medication might drastically alter the way obese people can lose weight effectively. Included are the top 5 research studies of tirzepatide/mounjaro. Check out how amazing this medicine is for losing weight!

If you live in Woodstock GA, or Atlanta GA this article will give a vast amount of data on how incredibly effective this medication is for medical weight loss.

Here are Key Points About Tirzepatide:

1) Mechanism of Action:

    • Tirzepatide works by mimicking the action of a natural hormone called glucagon-like peptide-1 (GLP-1). GLP-1 helps regulate blood sugar levels by stimulating insulin release and reducing glucagon secretion. Additionally, it slows down the emptying of the stomach, leading to a feeling of fullness.

2) Combination Therapy:

    • Tirzepatide is unique in that it combines the actions of GLP-1 receptor agonism with glucagon receptor agonism. This dual agonism is believed to provide more robust blood sugar control compared to traditional GLP-1 RAs.

3) Clinical Trials:

    • Clinical trials have shown promising results for tirzepatide in terms of improving glycemic control, reducing body weight, and potentially lowering the risk of cardiovascular events in people with type 2 diabetes.

4) Administration:

    • Tirzepatide is typically administered by subcutaneous injection. The frequency of administration can vary, and it may be taken once a week or less frequently, depending on the specific formulation.

5) Weight Loss Effects:

    • One notable aspect of tirzepatide is its association with weight loss. In clinical trials, patients taking tirzepatide experienced significant weight reduction, making it a potential option for individuals with type 2 diabetes who also struggle with obesity.

6) Side Effects:

    1. Like any medication, tirzepatide may have side effects. Common side effects can include nausea, vomiting, and diarrhea, especially when initiating treatment. It’s essential for individuals to discuss potential side effects with their healthcare provider.

7) Monitoring and Adjustments:

    • Regular monitoring of blood sugar levels and other relevant parameters is crucial when using tirzepatide. Dosage adjustments may be made based on an individual’s response and tolerability.

 STUDY NUMBER 1Weight loss efficiency and safety of Tirzepatide: A Systematic Review

Are you struggling with weight management while dealing with type 2 diabetes mellitus (T2DM) or obesity? There might be a promising solution on the horizon. In a recent meta-analysis study, researchers delved into the efficacy and safety of Tirzepatide, a novel drug that targets glucagon-like peptide-1 receptor (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) to tackle weight-related issues.

Research Approach

The investigation, spanning multiple databases including Cochrane Library, PubMed, Embase, Clinical Trials, and Web of Science, analyzed a comprehensive range of randomized controlled trials (RCTs). The goal was to provide a thorough understanding of Tirzepatide’s impact on weight loss in T2DM and obesity patients.

Weight Loss Efficacy

The results of the meta-analysis, involving ten studies and nearly 10,000 patients, unveiled promising outcomes. The Tirzepatide group exhibited a significant reduction in body weight compared to the placebo group, showcasing a substantial -9.81 kg difference. Notably, the weight loss surpassed that of GLP-1 receptor agonists (GLP-1 RAs) and insulin by -1.05 kg and -1.93 kg, respectively. Further sub-analysis revealed that Tirzepatide doses at 5 mg, 10 mg, and 15 mg consistently led to notable weight loss when compared to the control groups.

Safety Profile

While Tirzepatide demonstrated effectiveness in weight loss, it’s crucial to address safety concerns. The study noted a higher incidence of any adverse events and drug discontinuation due to adverse events in the Tirzepatide group. However, the incidence of serious adverse events and hypoglycemia was lower. Gastrointestinal adverse events, including diarrhea, nausea, vomiting, and decreased appetite, were more common with Tirzepatide compared to placebo/basal insulin but aligned with GLP-1 RAs.

Conclusion and Considerations

In conclusion, Tirzepatide emerges as a potent therapeutic option for weight loss in individuals with T2DM and obesity. The significant reduction in body weight, especially across different doses, positions Tirzepatide as a promising player in the battle against excess weight. However, the study advises caution regarding its gastrointestinal reactions. As further research unfolds, Tirzepatide holds the potential to reshape weight management strategies for those grappling with T2DM and obesity. Keep an eye on this innovative drug as it continues to pave the way for a healthier future.

Study Number 2- Tirzepatide once weekly for the treatment of Obesity

Background

Obesity is a global health concern associated with significant morbidity and mortality. This study aimed to assess the efficacy and safety of tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, in individuals with obesity.

Methods

  • Phase 3 double-blind, randomized, controlled trial.
  • 2539 adults with a BMI of 30 or more (or 27 or more with weight-related complications) were assigned to receive once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks.
  • Coprimary endpoints: Percentage change in weight from baseline and achieving a weight reduction of 5% or more.

Results

  • Baseline characteristics: Mean body weight 104.8 kg, mean BMI 38.0, 94.5% with BMI of 30 or higher.
  • Mean percentage change in weight at week 72:
    • -15.0% (5 mg tirzepatide)
    • -19.5% (10 mg tirzepatide)
    • -20.9% (15 mg tirzepatide)
    • -3.1% (placebo)
  • Percentage of participants with weight reduction of 5% or more:
    • 85% (5 mg)
    • 89% (10 mg)
    • 91% (15 mg)
    • 35% (placebo)
  • 50% and 57% in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, compared with 3% in the placebo group.

Cardiometabolic Measures

  • Improvements observed in all prespecified cardiometabolic measures with tirzepatide.

Adverse Events

  • Most common adverse events were gastrointestinal, mostly mild to moderate.
  • Adverse events led to treatment discontinuation in 4.3%, 7.1%, 6.2%, and 2.6% in the 5-mg, 10-mg, and 15-mg tirzepatide dose groups and placebo, respectively.

Conclusions

  • In this 72-week trial, tirzepatide once weekly (at doses of 5 mg, 10 mg, or 15 mg) provided substantial and sustained reductions in body weight.
  • Tirzepatide demonstrated favorable improvements in cardiometabolic measures.
  • Gastrointestinal adverse events were the most common, with a low rate of treatment discontinuation.

Note: The study was supported by Eli Lilly; ClinicalTrials.gov number, NCT04184622.

Study number 3Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction

In this fascinating study,Tirzepatide, a groundbreaking dual GIP/GLP-1 receptor co-agonist, has emerged as a game-changer in the treatment of type 2 diabetes, boasting unparalleled effectiveness in glycaemic control and body weight reduction.

Key Findings

  1. Unique Receptor Activation:
    • Tirzepatide is engineered to activate both GIP and GLP-1 receptors, critical players in insulin secretion and regulators of food intake in the brain.
  2. Clinical Trials Success (SURPASS 1-5):
    • Five clinical trials showcased remarkable outcomes:
      • HbA1c reduction: 1.24% to 2.58%
      • Body weight reduction: 5.4kg to 11.7kg
      • Substantial percentages achieved normoglycaemia (HbA1c < 5.7%) and over 10% weight loss.
  1. Comparative Superiority:
    • Tirzepatide outperformed selective GLP-1 RA semaglutide and titrated basal insulin in reducing HbA1c and body weight.
    • Adverse events mirrored those of selective GLP-1RA, with nausea, vomiting, diarrhea, and constipation reported.
  2. Cardiovascular Safety:
    • Cardiovascular events analysis demonstrated potential risk reduction over a 2-year period.
    • Hazard ratios for MACE (nonfatal myocardial infarction, non-fatal stroke, cardiovascular death, and hospital admission for angina) favored tirzepatide.
  3. Insulin Sensitivity and Secretory Responses:
    • Tirzepatide exhibited improved insulin sensitivity and secretory responses compared to semaglutide.
    • Lower prandial insulin and glucagon concentrations were observed.
  4. Appetite Reduction and Weight Loss:
    • Both tirzepatide and semaglutide caused appetite reduction, but tirzepatide led to greater weight loss.
  5. Remaining Questions:
    • Despite encouraging clinical effects, questions linger about the mechanism of action.
    • The therapeutic potential of GIP in humans, especially regarding food intake and insulin secretion, is still under scrutiny.

Conclusion

Tirzepatide’s remarkable performance in clinical trials, coupled with its comparative advantages over existing treatments, positions it as a promising therapeutic option for type 2 diabetes and obesity. While questions persist about its mechanism of action, the door is wide open for renewed exploration of GIP’s potential in addressing diabetes and related co-morbidities. As tirzepatide enters the spotlight, the landscape of diabetes management is poised for a transformative shift.

Study number 4-Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review

In the face of the escalating global challenges of obesity and diabetes, a groundbreaking solution has emerged—Tirzepatide, a ‘twincretin’ that marks a new era in dual-targeted treatment. This mini-review delves into the key characteristics of this first-in-class medication, exploring its synthesis, structure, activity, and the advancements it brings to diabetes and obesity management.

Key Highlights

  1. Unique Dual Agonist:
    • Tirzepatide is distinguished as the only dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) receptor agonist. Termed a ‘twincretin’, it offers a comprehensive approach to tackling diabetes and obesity simultaneously.
  2. Clinical Efficacy:
    • The drug has demonstrated its prowess in significantly reducing glycemic levels and improving insulin sensitivity.
    • Remarkably, Tirzepatide achieves a body weight reduction of more than 20%, setting it apart as a potent player in obesity management.
  3. Novel Synthesis and Administration:
    • As a synthetic peptide analog of human GIP, Tirzepatide incorporates a C20 fatty-diacid portion via acylation technology. This allows for binding to albumin, facilitating a once-weekly subcutaneous injection aligned with its five-day half-life.
  4. Brand Approval:
    • Developed by Eli Lilly, Tirzepatide received approval from the United States Food and Drug Administration under the brand name Mounjaro in May 2022. This landmark decision inaugurated the ‘twincretin’ era, introducing a pivotal dual therapeutic option for diabetes and obesity.
  5. Cardiometabolic Impact:
    • Beyond diabetes and obesity, Tirzepatide promises advanced management of cardiometabolic settings, addressing a leading cause of global morbidity, disability, and mortality.
  6. Evolution and Clinical Studies:
    • The mini-review traces the evolution of this groundbreaking medical agent, offering insights into its development through clinical studies. The post sheds light on Tirzepatide’s advantages while acknowledging potential shortcomings.

Tirzepatide, with its dual-targeted approach and unprecedented efficacy, stands as a beacon of hope in the quest for more effective and integrated solutions to the twin epidemics of diabetes and obesity. As we step into the ‘twincretin’ era, the future of diabetes and obesity management takes a promising turn, potentially reshaping global health outcomes.

Study number 5Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial

The SURMOUNT-3 phase 3 trial explores the impact of tirzepatide, a dual GIP and GLP-1 receptor agonist, on weight reduction following successful intensive lifestyle intervention in adults with overweight or obesity. Here’s a concise summary of the key findings:

Key Findings

  1. Study Design:
    • Double-blind, placebo-controlled trial.
    • Participants: Adults with BMI ≥30 or ≥27 kg/m² with at least one obesity-related complication (excluding diabetes).
    • Intensive lifestyle intervention precedes the trial, ensuring participants achieve ≥5.0% weight reduction.
  2. Tirzepatide Treatment:
    • Randomized participants to tirzepatide (maximum tolerated dose of 10 or 15 mg) or placebo once weekly for 72 weeks (n = 579).
  3. Primary Endpoints:
    • Mean Percent Weight Change: Tirzepatide demonstrated an additional mean percent weight change of -18.4% compared to 2.5% with placebo.
    • Percentage Achieving ≥5% Weight Reduction:5% with tirzepatide achieved this threshold, compared to 16.5% with placebo.
  4. Safety Profile:
    • Gastrointestinal adverse events were the most common with tirzepatide, mostly mild to moderate in severity.
  5. Statistical Significance:
    • The results were statistically significant, with a P-value < 0.001 for both primary endpoints.
  6. Conclusion:
    • Tirzepatide provided substantial additional reduction in body weight for participants who had already achieved ≥5.0% weight reduction through intensive lifestyle intervention.
  7. Clinical Implications:
    • The findings suggest that tirzepatide could be a promising adjunct to lifestyle interventions, offering an effective strategy for sustained weight reduction.
  8. gov Registration:
    • The trial is registered under NCT04657016.

The SURMOUNT-3 trial underscores the potential of tirzepatide in advancing weight management strategies, presenting a hopeful avenue for those navigating the challenges of obesity after successfully engaging in intensive lifestyle interventions. As research unfolds, tirzepatide continues to carve its place as a valuable asset in the fight against obesity-related complications.

In conclusion, these five research articles collectively highlight the positive benefits of tirzepatide/mounjaro in weight loss and related health outcomes. As with any medical intervention, it is essential for individuals to consult with healthcare professionals before incorporating tirzepatide/mounjaro into their weight management plans. The landscape of weight loss interventions is evolving, and tirzepatide/mounjaro appears to be a promising addition to the arsenal of options available.Now that the FDA has approved tirzepatide/mounjaro for weight loss due to obesity, it is something anyone looking to lose weight should look into.

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