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Drug Trial Snapshot: SOGROYA

The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the  SOGROYA Package Insert for complete information.

SOGROYA (somapacitan-beco)
Novo Nordisk Inc.
Approval date: August 28, 2020


What is the drug for?

SOGROYA is a drug for replacement of growth hormone in adults with growth hormone deficiency (GHD).

GHD is a condition when body doesn’t produce enough growth hormone on its own. Growth hormone regulates many functions in the body including accumulation of fat in the trunk or central area of the body that can be associated with serious medical issues.

How is this drug used?

SOGROYA is an injection given under the skin (subcutaneously) once every week

What are the benefits of this drug?

At the end of the trial, patients with GHD who were treated with SOGROYA experienced decrease of truncal fat percentage in comparison to placebo-treated patients who experienced increase in truncal fat percentage.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: SOGROYA worked similarly in men and women.
  • Race: SOGROYA worked similarly in Whites and Asians. The number of patients of other races was small; therefore, differences in how the drug worked in other races could not be determined.
  • Age: SOGROYA worked similarly in all age groups tested.

What are the possible side effects?

SOGROYA may cause serious side effects including:

  • Increased risk of growth of cancer that is already present and increased risk of the return of cancer
  • New or worsening high blood sugar
  • Increased intracranial pressure (pressure in the skull)
  • Serious allergic reactions
  • Body fluid retention
  • Decreased adrenal and thyroid gland function
  • Inflammation of pancreas and
  • Loss of fat tissue at the injection site

The most common side effects are back pain, joint pain, indigestion, sleep problems, dizziness, tonsillitis, swelling of the extremities, vomiting, decreased adrenal gland function, increased blood pressure, increase of blood creatine phosphokinase (type of enzyme), weight gain, and anemia.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The majority of patients were White. The number of patients in other races was small. Therefore, differences in side effects among races could not be determined.
  • Age: The majority of patients were younger than 65 years of age. The number of patients older than 65 years of age was small. Therefore, differences in side effects in patients older than 65 years of age could not be determined.


Who participated in the clinical trials?

The FDA approved SOGROYA based on evidence from one clinical trial (NCT02229851) of 300 adult patients with growth hormone deficiency. The trial was conducted at 92 sites in 16 countries: United States, Australia, Germany, India, Japan, Latvia, Lithuania, Malaysia, Poland, Romania, Russian Fed, South Africa, Sweden, Turkey, Ukraine and United Kingdom.

Figure 1 summarizes how many men and women were in the clinical trial.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial. In total, 155 women (52%) and 145 men (48%) participated in the clinical trial.

FDA Review

Figure 2 summarizes the percentage of participants by race.

Figure 2. Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 200 White (67%), 7 Black or African American  (2%), 86 Asian (29%) and 7 Other (2%)

*Includes Native Hawaiian or Other Pacific Islander, Other, and Not reported

FDA Review

Figure 3 summarizes participants by age.

Figure 3. Demographics by Age

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  259 (86%) were less than 65 and 41 patients were 65 years and older (14%).

FDA Review

Figure 4 summarizes participants by ethnicity

Figure 4. Demographics by Ethnicity

Pie charts summarizing ethnicity of patients enrolled in the clinical trial. In total,  18 patients were Hispanic or Latino (6%) and 280 patients were not Hispanic or Latino (93%).

FDA Review

How were the trials designed?

The benefit and side effects of SOGROYA as a replacement therapy for GHD were assessed in one trial.

Adult patients were assigned at random to weekly SOROGOYA or placebo injections for 34 weeks. Neither the patients nor the investigators knew which treatment was given until the end of the trial. One additional group of patients with GHD received daily injections of somatotropin (an approved treatment for GHD).

The benefit of SOROGOYA was assessed by measuring a change in truncal fat percentage using a special imaging technique and comparing it to placebo.


CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.


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