Peptide education
Somapacitan
Somapacitan-beco · Sogroya
Somapacitan-beco is a long-acting growth hormone analog. The US prescription product Sogroya is given by subcutaneous injection once a week for specific growth disorders in children and growth hormone deficiency in adults.
In REAL4, prepubertal children with growth hormone deficiency grew at an estimated 11.2 cm per year on weekly somapacitan and 11.7 cm per year on daily somatropin over the first 52 weeks. The trial met its noninferiority criterion.
Overview
Quick answer
Somapacitan supplies a growth hormone analog; it does not stimulate the pituitary to release growth hormone. Weekly Sogroya doses are not interchangeable milligram for milligram with daily somatropin doses.
Who is Sogroya prescribed for?
The US label covers adults with growth hormone deficiency and children aged 2.5 years or older with growth failure from growth hormone deficiency, short stature in children born small for gestational age without catch-up growth by age 2, growth failure associated with Noonan syndrome, or idiopathic short stature.
What did the pediatric trial find?
REAL4 randomized 200 prepubertal children with growth hormone deficiency to weekly somapacitan or daily somatropin. Estimated height velocity at week 52 was 11.2 and 11.7 cm per year, respectively.
What did the adult trial measure?
REAL 1 studied adults with growth hormone deficiency who had never received growth hormone or had been off it for at least six months. At week 34, the estimated change in truncal fat percentage was 1.53 percentage points lower with somapacitan than placebo.
What safety issues matter?
The label warns about glucose intolerance, fluid retention, intracranial hypertension and neoplasms. It contraindicates use in specified acute critical illness, active malignancy, and active proliferative or severe non-proliferative diabetic retinopathy.
Evidence
Evidence snapshot
REAL4 found 11.2 cm per year with weekly somapacitan and 11.7 cm per year with daily somatropin in prepubertal children. The randomized comparison was open-label.
REAL 1 found a 1.53 percentage-point greater reduction in truncal fat percentage than placebo after 34 weeks.
The label also covers specified small-for-gestational-age short stature, growth failure associated with Noonan syndrome and idiopathic short stature from age 2.5 years.
Glucose intolerance, edema, intracranial hypertension and neoplasm concerns require consideration during care.
Claims
Common claims vs evidence
| Claim | Human evidence | Verdict |
|---|---|---|
| Weekly somapacitan supports growth in children with GHD. | REAL4 found that annualized height velocity at 52 weeks met the study's noninferiority criterion against daily somatropin in treatment-naive, prepubertal children. | Supported for the studied population and reflected in the US label. |
| The adult trial establishes a weight-loss treatment for healthy adults. | REAL 1 enrolled adults with growth hormone deficiency who had never received growth hormone or had been off it for at least six months. It measured truncal fat percentage during replacement, not general weight-loss treatment. | The study does not establish that broader use. |
| Weekly and daily growth hormones can be exchanged at the same milligram dose. | REAL4 used 0.16 mg/kg weekly somapacitan and 0.034 mg/kg daily somatropin. Sogroya's label specifies its own switching and dosing instructions. | No. The molecule, schedule and product label differ. |
Bottom line
Main takeaway
Sogroya is a weekly growth hormone medicine for specific diagnosed conditions.
The pediatric starting dose depends on the diagnosis; adults with GHD use a different starting schedule.
REAL4 measured first-year height velocity; REAL 1 measured change in truncal fat percentage in adults with GHD.
Identity
What it is
Somapacitan is a modified growth hormone analog that binds reversibly to albumin. That property extends its activity relative to daily preparations.
Sogroya is supplied in prefilled pens and administered subcutaneously once weekly. Its US label specifies the qualifying conditions and age limits.
Use context
Routes, doses, and cycle patterns
Sogroya doses vary by age, diagnosis, treatment response and other clinical factors.
Human studies and product labels
Pediatric growth hormone deficiency
- Purpose
- Treatment of growth failure due to GHD
- Context
- US prescribing information
- Route
- Subcutaneous injection
- Amount
- 0.16 mg/kg based on actual body weight
- Frequency
- Once weekly
The label specifies this starting dose for treatment-naive patients and patients switching from daily somatropin.
Other labeled pediatric indications
- Purpose
- Specified SGA short stature, Noonan syndrome or idiopathic short stature
- Context
- US prescribing information
- Route
- Subcutaneous injection
- Amount
- 0.24 mg/kg based on actual body weight
- Frequency
- Once weekly
The labeled pediatric population is aged 2.5 years and older; dose is individualized to growth response.
Adult growth hormone deficiency
- Purpose
- Growth hormone replacement
- Context
- US prescribing information, general starting dose
- Route
- Subcutaneous injection
- Amount
- 1.5 mg initially
- Frequency
- Once weekly, with response-based titration
The label specifies different starting doses for certain groups, including older adults, patients with hepatic impairment and women taking oral estrogen.
REAL4 pediatric trial
- Purpose
- Compare first-year growth velocity in prepubertal children with GHD
- Context
- Randomized open-label study
- Route
- Subcutaneous injection
- Amount
- 0.16 mg/kg somapacitan
- Frequency
- Once weekly
- Duration
- 52-week main period
The comparator was daily somatropin at 0.034 mg/kg per day.
Research
Research evidence
REAL4 compared growth velocity in children with GHD. REAL 1 compared truncal fat change against placebo in adults with GHD; the daily growth hormone arm was open-label.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| REAL4 | 200 treatment-naive, prepubertal children with growth hormone deficiency | Randomized open-label active-controlled phase 3 study | Weekly somapacitan 0.16 mg/kg versus daily somatropin 0.034 mg/kg | At week 52, estimated height velocity was 11.2 versus 11.7 cm per year; noninferiority was met. | The primary comparison measured first-year growth, not final adult height, and treatment was open-label. | Randomized, pediatric GHD |
| REAL 1 | 301 adults with growth hormone deficiency who had never received GH or had been off GH for at least six months | Randomized phase 3 study with double-blind placebo and open-label daily GH comparisons | Weekly somapacitan, weekly placebo or daily growth hormone | Change in truncal fat percentage favored somapacitan over placebo by an estimated 1.53 percentage points at week 34. | The active comparator was open-label and the population had diagnosed GHD. | Randomized, adult GHD |
Cautions
Safety and unknowns
- Sogroya is contraindicated in specified acute critical illnesses, active malignancy, active proliferative or severe non-proliferative diabetic retinopathy, and children with closed growth plates.
- Growth hormone treatment can decrease insulin sensitivity and may cause fluid retention, intracranial hypertension or changes in thyroid or adrenal function.
- Hip or knee pain or limping in a child can indicate slipped capital femoral epiphysis. The label also warns about hypersensitivity and pancreatitis.
- The label contraindicates use in children with Prader-Willi syndrome who have severe obesity or specified respiratory risk factors. Sogroya is not labeled to treat Prader-Willi syndrome.
Mechanism
How it is proposed to work
Somapacitan activates growth hormone receptors and increases IGF-1, a signal involved in growth and metabolism.
Reversible albumin binding slows clearance and supports once-weekly administration.
Adult dose adjustment uses clinical response and IGF-1 measured at the time specified in the label.
Details
Technical details
Sources
References
- 1.
DailyMed. Sogroya prescribing information
US label for somapacitan-beco, including indications, weekly dosing and growth hormone safety warnings.
- 2.
PubMed. Once-weekly somapacitan in adults with growth hormone deficiency: REAL 1
doi:10.1210/clinem/dgaa049 PMID:32022863 NCT02229851
Randomized phase 3 adult GHD trial with a placebo-controlled main period and an open-label daily GH arm.
- 3.
PubMed. Weekly somapacitan in children with growth hormone deficiency: REAL4
doi:10.1210/clinem/dgac513 PMID:36062966 NCT03811535
Randomized open-label phase 3 comparison of weekly somapacitan and daily somatropin in children with GHD.