- Open label
- Multicenter
- Randomized
- Crossover
- Single dose
How was Macrilen™ studied?
Macrilen™ was studied in 140 adults in a head-to-head trial versus the current standard of care, the insulin tolerance test (ITT).1,2,a,b The positive agreement refers to the percentage of subjects who tested positive for AGHD with both tests, while the negative agreement correlates to the percentage of subjects who tested negative on both tests.
How was Macrilen™ studied?
Macrilen™ was studied in 140 adults in a head-to-head trial versus the current standard of care, the insulin tolerance test (ITT).1,2,a,b The positive agreement refers to the percentage of subjects who tested positive for AGHD with both tests, while the negative agreement correlates to the percentage of subjects who tested negative on both tests.
Co-primary endpoints
Percentage of positive and negative agreement between Macrilen™ and ITT based on prespecified GH cut-point values
Positive agreement, subjects with both a positive ITT and Macrilen™ test. Negative agreement, subjects with both a negative ITT and Macrilen™ test. All subjects included those with a high (n=38), intermediate (n=37), or low (n=40) likelihood of AGHD, as well as healthy controls (n=25).1
- Open label
- Multicenter
- Randomized
- Crossover
- Single dose
Co-primary endpoints
Percentage of positive and negative agreement between Macrilen™ and ITT based on prespecified GH cut-point values
Positive agreement, subjects with both a positive ITT and Macrilen™ test. Negative agreement, subjects with both a negative ITT and Macrilen™ test. All subjects included those with a high (n=38), intermediate (n=37), or low (n=40) likelihood of AGHD, as well as healthy controls (n=25).1
The prespecified cut-point value for a diagnosis of AGHD with Macrilen™ was a maximally stimulated serum GH level of <2.8 ng/mL for the 4 blood draws.1
The prespecified cut-point value for a diagnosis of AGHD with Macrilen™ was a maximally stimulated serum GH level of <2.8 ng/mL for the 4 blood draws.1
aEnrolled safety and modified intention-to-treat (mITT) populations: Of 166 enrolled subjects, 157 underwent one stimulation test and formed the safety population. 154 subjects had both stimulation tests at least once. Of 157 subjects, 17 did not fulfill the mITT criterion (randomized subjects in whom both tests of the crossover were evaluable).2
bStudied in adult subjects with different pretest probabilities of GH deficiency (GHD) and in healthy control subjects.1
Who was tested for AGHD?
In the head-to-head trial versus ITT, adults were segmented into the following groups to compare levels of agreement between Macrilen™ test results and ITT results.1
Who was tested for AGHD?
In the head-to-head trial versus ITT, adults were segmented into the following groups to compare levels of agreement between Macrilen™ test results and ITT results.1
High likelihood of GHD
(n=38)
- Structural hypothalamic or pituitary lesions and low insulin-like growth factor-1 (IGF-1)
- 3 or more pituitary hormone deficiencies and low IGF-1
- Childhood-onset GHD with structural lesions and low IGF-1
- Structural hypothalamic or pituitary lesions and low insulin-like growth factor-1 (IGF-1)
- 3 or more pituitary hormone deficiencies and low IGF-1
- Childhood-onset GHD with structural lesions and low IGF-1
Intermediate likelihood of GHD
(n=37)
- Subjects who do not qualify for either high or low likelihood
- Subjects who do not qualify for either high or low likelihood
Low likelihood of GHD
(n=40)
- Subjects with only 1 risk factor for GHD, such as
- History of distant traumatic brain injury
- Only 1 pituitary hormone deficiency with otherwise normal pituitary function
- Isolated idiopathic childhood-onset GHD without additional pituitary deficits
- Subjects with only 1 risk factor for GHD, such as
- History of distant traumatic brain injury
- Only 1 pituitary hormone deficiency with otherwise normal pituitary function
- Isolated idiopathic childhood-onset GHD without additional pituitary deficits
Healthy controls
(n=25)
- Healthy subjects matching subjects in high-likelihood group by sex, age (±5 years), BMI (±2 kg/m2), and estrogen status (females only)
- Healthy subjects matching subjects in high-likelihood group by sex, age (±5 years), BMI (±2 kg/m2), and estrogen status (females only)
Overall diagnostic accuracy of Macrilen™
Correlation overall in those with a high likelihood of AGHD1
Overall diagnostic accuracy of Macrilen™
Correlation overall in those with a high likelihood of AGHD1
Type of correlation
All subjects
High likelihood of AGHD
Positive
74%
89%
Negative
94%
100%
Overall
84%
89%
cDefined as neuroglycopenic signs and symptoms confirmed by glucose less than 40 mg/dL.
Macrilen™ results were reproducible in more than 91% of patients tested.1
Macrilen™ results were reproducible in more than 91% of patients tested.1
Well-tolerated safety profile in a clinical trial2
Common adverse events reported in <5% of subjects1
Well-tolerated safety profile in a clinical trial2
Common adverse events reported in <5% of subjects1
No AEs led to failure to compile the Macrilen™ test.1
No AEs led to failure to compile the Macrilen™ test.1
How to prepare for dosing
Review the step-by-step process for preparing and administering Macrilen™.
How to prepare for dosing
Review the step-by-step process for preparing and administering Macrilen™.
How to order
Learn how you can start ordering Macrilen™ for your patients.
How to order
Learn how you can start ordering Macrilen™ for your patients.