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Placebo and Saizen®
Saizen® is a recombinant human growth hormone that replaces or supplements endogenous growth hormone to promote growth and metabolic effects.
Saizen® is a recombinant human growth hormone that replaces or supplements endogenous growth hormone to promote growth and metabolic effects. Used for Growth hormone deficiency (likely indication based on Saizen® approved uses), Short stature or growth disorders (potential Phase 3 indication).
At a glance
| Generic name | Placebo and Saizen® |
|---|---|
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Drug class | Recombinant human growth hormone |
| Target | Growth hormone receptor (GHR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Saizen® (somatropin) is a synthetic form of human growth hormone (hGH) produced via recombinant DNA technology. It binds to growth hormone receptors on target tissues, stimulating linear growth, protein synthesis, and lipolysis while affecting carbohydrate and mineral metabolism. The trial appears to be comparing Saizen® efficacy and safety against placebo in a growth hormone-deficient or growth-related indication.
Approved indications
- Growth hormone deficiency (likely indication based on Saizen® approved uses)
- Short stature or growth disorders (potential Phase 3 indication)
Common side effects
- Injection site reactions
- Headache
- Arthralgia
- Carpal tunnel syndrome
- Fluid retention
- Hyperglycemia
Key clinical trials
- Effects of Ketone Bodies on Insulin Sensitivity (NA)
- A Clinical Study of GenSci134 in Healthy Male Adults (PHASE1)
- Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients (PHASE4)
- Growth Hormone Replacement Therapy for Retried Professional Football Players (PHASE2)
- Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone (PHASE2, PHASE3)
- Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. (PHASE3)
- Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus (HIV) Patients (PHASE3)
- A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |