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As a high-performer, you’re used to optimizing every aspect of your life for success. But when you experience persistent fatigue, brain fog, or a frustrating loss of muscle mass, it can feel like you’ve hit a wall that hard work can’t break through. These symptoms aren’t just signs of a demanding schedule; they can point to Adult Growth Hormone Deficiency (AGHD). Getting a clear diagnosis is the first step toward taking back control. The Macrilen test provides a non-invasive, FDA-approved method to accurately measure your body’s growth hormone response, giving you the data needed to move beyond guesswork.

Macimorelin: A Breakthrough in Diagnosing Adult Growth Hormone Deficiency (AGHD)

Published on: March 9, 2025

Introduction

Macimorelin has emerged as a leading diagnostic tool for Adult Growth Hormone Deficiency (AGHD), offering a non-invasive, FDA-approved alternative to traditional testing methods. Since growth hormone (GH) plays a critical role in metabolism, muscle growth, and bone density, a decline in GH levels can significantly impact health. As individuals age, their GH production naturally decreases, leading to metabolic shifts, reduced energy levels, and an increased risk of chronic health conditions. Because early diagnosis is essential, Macimorelin provides an effective solution for identifying growth hormone deficiencies before they lead to long-term health issues.

Understanding Growth Hormone Decline in Men and Women

Aging results in a gradual but measurable decrease in GH production in both men and women. This hormonal decline can negatively impact body composition, cardiovascular health, and overall well-being. While some individuals may experience mild symptoms, others develop Adult Growth Hormone Deficiency (AGHD), which requires medical intervention.

How Growth Hormone Decline Affects the Body

  • Increased body fat accumulation, especially around the abdomen
  • Decreased muscle mass and strength, making it harder to maintain lean tissue
  • Reduced bone mineral density, leading to osteoporosis risks
  • Slower metabolism, resulting in insulin resistance and weight gain
  • Cognitive decline, including memory issues and brain fog

Because AGHD can affect multiple physiological systems, identifying growth hormone imbalances early allows individuals to explore hormonal optimization strategies that improve long-term health.

The Challenge of Measuring Growth Hormone Directly

Pinpointing a growth hormone deficiency isn’t as simple as a single blood draw. That’s because your body releases growth hormone (GH) in short, powerful bursts throughout the day, not in a steady stream. This means your GH levels can be high one moment and low the next, making a random test result potentially misleading. For years, the standard diagnostic method was the insulin tolerance test (ITT), an invasive procedure that involves inducing hypoglycemia. Understandably, this test carries risks and isn’t a practical or comfortable option for routine screening. For high-performing individuals who need clear, reliable data without significant disruption, this old-school approach just doesn’t cut it.

Why IGF-1 is a Key Marker

Instead of trying to catch the fleeting spikes of GH, a much more reliable approach is to measure Insulin-like Growth Factor 1 (IGF-1). Your liver produces IGF-1 in response to growth hormone, but unlike GH, its levels remain stable in your bloodstream throughout the day. This stability makes IGF-1 an excellent proxy, as it reflects your average GH production over time, giving a far more accurate picture of your hormonal health. It’s a critical piece of the puzzle when diagnosing Adult Growth Hormone Deficiency (AGHD).

This is why comprehensive testing at 1st Optimal always includes an analysis of IGF-1. Furthermore, modern diagnostic tools like the oral macimorelin test, a non-invasive alternative to the ITT, have been shown to correlate strongly with IGF-1 levels, further cementing its role as the gold-standard marker. By focusing on stable, accurate data points like IGF-1, we can confidently identify imbalances and create a precise plan to restore your vitality.

Macimorelin: A Non-Invasive Diagnostic Tool for AGHD

Macimorelin, known under the trade name Macrilen, is a ghrelin receptor agonist designed to stimulate growth hormone secretion from the pituitary gland. Unlike invasive GH stimulation tests, Macimorelin provides a patient-friendly alternative for assessing GH levels with a simple oral administration.

Key Benefits of Macimorelin Testing

  • Non-invasive, oral administration – No injections or IVs required
  • Clinically validated for accuracyFDA-approved for AGHD diagnosis
  • Fast results – Provides GH level analysis in a controlled setting
  • Safer than the insulin tolerance test (ITT) – Minimizes risks associated with hypoglycemia

FDA Approval and Clinical Research on Macimorelin

The U.S. Food and Drug Administration (FDA) approved Macimorelin in December 2017 for the diagnosis of Adult Growth Hormone Deficiency. Clinical trials demonstrated that this oral growth hormone stimulation test was both safe and effective, with results comparable to traditional GH stimulation methods.

Research has confirmed that Macimorelin testing offers:

  • Sensitivity and specificity comparable to ITT
  • Fewer risks than traditional GH stimulation tests
  • An efficient and convenient alternative to invasive diagnostic procedures

Because GH deficiency affects metabolic function, early detection using Macimorelin allows for faster interventions that support hormonal balance and overall health.

Clinical Performance: How Accurate is the Macimorelin Test?

When considering any medical diagnostic, the first question is always: “How well does it work?” For a test to be truly valuable, it needs to be both accurate and reliable. Accuracy means it gives you the right answer, while reliability means it gives you the same answer consistently. Clinical studies on Macimorelin have focused on these exact points, comparing its performance to the long-standing Insulin Tolerance Test (ITT). The results show that Macimorelin not only holds its own in terms of precision but also offers significant advantages in safety and patient experience, which is a critical factor for busy professionals who need clear answers without unnecessary risks or disruptions.

Sensitivity, Specificity, and Agreement with ITT

In diagnostics, two terms matter most: sensitivity and specificity. Think of sensitivity as the test’s ability to correctly identify people who have AGHD. Specificity is its power to correctly rule out the condition in those who don’t. Research demonstrated that Macimorelin is highly effective, with 92% sensitivity and 96% specificity when using a specific growth hormone threshold. This level of accuracy is comparable to the ITT but comes without the most significant drawback: the ITT requires inducing hypoglycemia (dangerously low blood sugar), which can be risky and unpleasant. Macimorelin avoids this completely, making it a much safer and more comfortable diagnostic experience.

Test Reproducibility and Completion Rate

A diagnostic test is only useful if its results are dependable and can be consistently replicated. Macimorelin excels here, with studies showing a 97% reproducibility rate. This means if you were to take the test again, there’s a very high probability you’d get the same result, giving you and your doctor confidence in the diagnosis. Furthermore, the test is incredibly straightforward to complete. Clinical trial data showed a 99% completion rate for Macimorelin, meaning nearly every test administered provided a usable result. This stands in stark contrast to the ITT, which has a completion rate of only 82%, often failing due to procedural issues or patient intolerance.

Performance Across Different Patient Groups

It’s fair to ask if a test works equally well for everyone. For Macimorelin, the answer is a resounding yes. Studies have analyzed its performance across different demographics and found that its accuracy is not significantly impacted by a person’s age, sex, or Body Mass Index (BMI), as long as they fall within the studied ranges. This consistency is crucial, as it confirms that Macimorelin is a reliable tool for both men and women across a wide age spectrum who are looking to understand their hormonal health. The test’s overall accuracy was found to be exceptionally high—around 99%—reinforcing its standing as a dependable diagnostic for AGHD.

Who Was Included in the Studies? (Study Limitations)

Transparency is key to making informed health decisions, and that includes understanding the limits of clinical research. The pivotal studies on Macimorelin included adult participants between the ages of 18 and 66 with a Body Mass Index (BMI) under 37 kg/m². This means the test’s high accuracy and reliability are most clearly established for individuals who fit this profile. The findings may not directly apply to those outside these parameters, such as adolescents, older adults, or individuals with severe obesity. This is precisely why a personalized, data-driven approach is so critical. At 1st Optimal, our medical team evaluates your complete health profile to determine the most effective diagnostic path, ensuring that any test we recommend is appropriate for your unique physiology and health goals.

Macimorelin Dosage and Administration

For accurate GH assessment, Macimorelin is administered as a single oral dose of 0.5 mg/kg body weight. Patients should fast for at least eight hours before taking the test. After ingestion, growth hormone levels are measured over a 90-minute period to evaluate the pituitary gland’s response.

Safety Profile and Potential Side Effects

While Macimorelin is a significant step forward in diagnostic testing, it’s important to understand its safety profile. Overall, it is considered a very safe procedure, especially when compared to older methods. Knowing what to expect can help you feel more prepared and confident on the day of your test, which is a key part of taking control of your health journey.

Common Side Effects and What to Watch For

One of the key benefits of Macimorelin is its favorable safety profile, particularly when contrasted with the traditional insulin tolerance test (ITT), which carries a risk of severe low blood sugar. While research confirms Macimorelin does not cause serious side effects, some individuals may experience mild, temporary reactions. The most common ones include a change in taste, dizziness, headache, or increased hunger. Some also report mild, flu-like symptoms like body aches or a runny nose. These effects are typically short-lived and resolve on their own without any need for intervention. Discussing these possibilities with your provider beforehand ensures you know what is normal for the procedure.

Important Precautions and Drug Interactions

For the Macimorelin test to yield accurate and safe results, a thorough review of your health history is essential. It is important to inform your doctor about any existing hormonal imbalances, such as low steroid, sex, or thyroid hormones, as they may recommend addressing these before the test. This is a standard part of a comprehensive approach to ensure diagnostic clarity. Additionally, certain medications can interfere with Macimorelin and should not be taken at the same time. These include specific drugs like Bepridil, Cisapride, and Fluconazole. Your medical team will carefully review your current medications to prevent any negative interactions and confirm the test is appropriate for you.

How Macimorelin Works in the Body

  1. Stimulates the ghrelin receptor, prompting the pituitary gland to release GH
  2. Triggers natural GH production, allowing for measurement of secretion levels
  3. Provides fast and reliable data on the body’s ability to produce GH

Macimorelin vs. Other GH Secretagogues and Stimulation Tests

Macimorelin is part of a class of growth hormone secretagogues, compounds designed to stimulate GH release. Compared to other diagnostic methods, Macimorelin stands out due to its oral administration and superior safety profile.

Comparison of Growth Hormone Stimulation Methods

Test/Compound Administration Mechanism of Action FDA Approval Status
Macimorelin Oral Ghrelin receptor agonist Approved for AGHD diagnosis
Insulin Tolerance Test (ITT) IV Hypoglycemia-induced GH release Approved but high risk
Arginine-GHRH Test IV Stimulates GH secretion Limited availability
Ibutamoren (MK-677) Oral Ghrelin receptor agonist Not FDA-approved for GH testing

Since Macimorelin offers a non-invasive, validated alternative, it is becoming the preferred choice for diagnosing AGHD.

A Closer Look at the Insulin Tolerance Test (ITT) and Its Risks

For years, the Insulin Tolerance Test (ITT) was the standard for diagnosing adult growth hormone deficiency. The test works by using an IV to administer insulin, which intentionally lowers your blood sugar. This stress prompts the pituitary gland to release growth hormone, allowing doctors to measure the response. While effective, this method has significant drawbacks. The procedure is complex, requires close medical supervision in a hospital setting, and is often an uncomfortable and demanding experience for the patient. Because of these challenges, it’s no longer the preferred method for individuals seeking efficient and safe diagnostic solutions that fit into a busy lifestyle.

The most critical issue with the ITT is the inherent safety risk. The test’s entire mechanism relies on inducing hypoglycemia, or dangerously low blood sugar, which can be difficult to manage. This condition can cause symptoms like dizziness, confusion, and heart palpitations, and in severe cases, may even lead to seizures. These risks make the ITT unsuitable for many individuals, particularly those with pre-existing heart conditions or a history of seizures. The development of safer, simpler, and more reliable oral tests like Macimorelin provides a much-needed modern alternative, allowing for accurate diagnosis without the significant risks and discomfort associated with the ITT.

Health Benefits of Diagnosing AGHD Early

Identifying growth hormone deficiencies before they impact metabolism, muscle function, and mental clarity allows individuals to take proactive steps toward optimizing their hormonal health.

Key Health Benefits of Growth Hormone Optimization

  • Improved body composition through enhanced fat metabolism
  • Stronger muscle mass and physical performance
  • Better bone density and reduced osteoporosis risk
  • Improved cardiovascular function and cholesterol balance
  • Greater energy levels and cognitive function

Because growth hormone supports multiple physiological functions, early intervention ensures better long-term health outcomes.

Who Should Consider Macimorelin Testing?

Macimorelin testing is ideal for individuals experiencing symptoms of growth hormone deficiency, including:

  • Unexplained fatigue and low energy levels
  • Loss of muscle mass and increased body fat
  • Difficulty recovering from exercise
  • Cognitive decline, brain fog, and poor memory
  • Metabolic dysfunction and insulin resistance

Additionally, athletes and those considering peptide therapies should evaluate their growth hormone levels to determine whether hormonal optimization strategies are necessary.

Current Availability of the Macrilen Test in the U.S.

If you’re looking to get the Macrilen test, it’s important to know its current status. While macimorelin is FDA-approved and recognized as a valuable diagnostic tool, its commercial sales in the United States are temporarily discontinued. The manufacturer is working to find a new partner to re-launch the test, so it is not available on the market at this time. This pause can be frustrating, but it doesn’t change the test’s underlying clinical value. It simply means that for now, patients and practitioners need to rely on other established methods for assessing growth hormone levels.

The reason Macrilen’s temporary absence is significant is because of what it represents: a major step forward in hormone diagnostics. Approved by the FDA in 2017, clinical research has consistently shown it to be a safe and effective way to diagnose Adult Growth Hormone Deficiency. Unlike the invasive and often uncomfortable Insulin Tolerance Test (ITT), Macrilen is a simple oral solution, making it a much more patient-friendly option. Its accuracy is comparable to older methods but without the associated risks, which is why it remains a benchmark for convenient and reliable GH testing.

So, what does this mean for you right now? While we await Macrilen’s return, you don’t have to put your health goals on hold. At 1st Optimal, we use a comprehensive, data-driven approach to understand your complete hormonal landscape. We assess growth hormone function by analyzing key biomarkers, like IGF-1, alongside a full panel of other relevant labs. This allows us to identify imbalances and create a personalized strategy to restore your energy and performance without relying on a single test. It’s about looking at the complete picture to build a foundation for your long-term health.

Final Thoughts on Macimorelin and Growth Hormone Deficiency

Macimorelin has redefined growth hormone deficiency diagnosis, providing a safe, effective, and FDA-approved method for evaluating GH production. As growth hormone levels naturally decline, maintaining optimal endocrine function becomes increasingly important for metabolic health, muscle preservation, and long-term vitality.

Since GH deficiency can impact body composition, cardiovascular function, and cognitive performance, early diagnosis allows for targeted interventions, peptide therapies, and hormone optimization strategies. Whether for longevity, athletic performance, or general well-being, ensuring balanced GH levels is essential for maintaining optimal health.

For individuals seeking a trusted and non-invasive approach to diagnosing GH deficiency, Macimorelin testing provides an effective solution. Consulting with a healthcare provider about growth hormone evaluation and optimization strategies is a proactive step toward improving overall quality of life and long-term health outcomes.

Ready to Find Answers? Let’s Talk.

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References

  1. Garcia JM, Biller BMK, Korbonits M, et al. Macimorelin as a Diagnostic Test for Adult GH Deficiency. J Clin Endocrinol Metab. 2018;103(8):3083-3093.

  2. Drug Trials Snapshots: Marcrilen. U.S. Food and Drug Administration.

  3. Garcia JM, Boccia RV, Graham CD, et al. Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia: a report from the Growth Hormone Secretagogue Receptor Agonist in Cancer Patients with Anorexia-Cachexia Trial (GHASCAT) study group. J Cachexia Sarcopenia Muscle. 2023;14(2):456-465.

  4. Macrilen (macimorelin) FDA Approval History. Drugs.com.

  5. COSCIENS Biopharma Inc. Announces Top-Line Results of Phase 3 DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency. BioSpace.

Note: This article is intended for informational purposes and should not replace professional medical advice. Consult a healthcare provider for personalized guidance.

Frequently Asked Questions

Why can’t my doctor just run a simple blood test for growth hormone? That’s a great question. The challenge with growth hormone (GH) is that your body releases it in short bursts, not in a steady stream. This means your levels can be high one moment and low the next, making a single blood draw an unreliable snapshot of your overall production. Instead, we look at more stable markers like Insulin-like Growth Factor 1 (IGF-1). Your liver produces IGF-1 in response to GH, and its levels stay consistent throughout the day, giving us a far more accurate picture of your hormonal health.

I’ve heard about the Insulin Tolerance Test (ITT). How is the Macrilen test a better option? For a long time, the ITT was the standard for diagnosing growth hormone deficiency. It works by intentionally lowering your blood sugar with insulin to trigger a GH response. As you can imagine, this is an invasive and uncomfortable procedure that carries risks and requires close medical supervision. The Macrilen test is a major step forward because it’s a simple oral solution. You drink it, and we measure the response. It provides highly accurate results without the risks and discomfort associated with the ITT.

The blog post says the Macrilen test is temporarily unavailable. How can I find out if I have a growth hormone deficiency right now? It’s true that the manufacturer has paused commercial sales of the test, but that doesn’t mean you have to put your health on hold. A single test is only one piece of the puzzle. At 1st Optimal, we use a comprehensive diagnostic approach that looks at your entire hormonal landscape. By analyzing key biomarkers like IGF-1 alongside a full panel of other relevant labs, we can still get a clear understanding of your growth hormone function and create a precise, data-driven plan to get you back to feeling your best.

What does the Macrilen test actually feel like? Are there significant side effects? The process itself is very straightforward—you simply drink the oral solution on an empty stomach. While the test is considered very safe, some people experience mild, temporary side effects. The most common ones are a change in taste (sometimes described as metallic), dizziness, a mild headache, or feeling a bit hungry. These effects typically pass quickly on their own and are not considered serious.

Who should be thinking about getting their growth hormone levels checked? You should consider looking into your growth hormone levels if you’re a high-performer who feels like something is off, but you can’t pinpoint why. This is especially true if you’re experiencing persistent fatigue that sleep doesn’t fix, a frustrating loss of muscle mass despite working out, stubborn body fat, or a general sense of brain fog that impacts your focus. These aren’t just signs of a busy life; they can be indicators of an underlying hormonal imbalance that we can identify and address.

Key Takeaways

  • Traditional AGHD testing is outdated and risky: Accurately diagnosing Adult Growth Hormone Deficiency is challenging, and the old gold-standard test (the ITT) is invasive and carries significant safety concerns, making it a poor fit for proactive individuals.
  • Macimorelin offers a modern, data-driven diagnosis: As an FDA-approved oral test, Macimorelin provides a highly accurate and reliable way to assess growth hormone function without the risks or inconvenience of older methods, giving you the clear data needed to make informed decisions.
  • A complete hormonal picture is non-negotiable: While the Macrilen test is temporarily off the market, you can still get answers. A comprehensive evaluation using key biomarkers like IGF-1 provides a robust understanding of your hormonal health, allowing you to move forward with a personalized optimization strategy now.

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