drugset / Trial / NCT02229851
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.
Timeline
- Start
- 2014-10-31
- Primary completion
- 2017-04-21
- Completion
- 2018-05-07
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Somapacitan; p =0.0090; Treatment difference -1.53 (95% CI -2.68 to -0.38); ANCOVA NCT02229851 ↗
paper At 34 weeks, somapacitan significantly reduced truncal fat percentage (estimated difference: -1.53% [-2.68; -0.38]; P = 0.0090), demonstrating superiority compared with placebo PMID 32022863 ↗
Publications
- Results Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.
- Otsuka F, Rasmussen MH, Endo T, Svaerke C, Tahara S, Johannsson G. Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial. Front Endocrinol (Lausanne). 2025 Feb 7;16:1534891. doi: 10.3389/fendo.2025.1534891. eCollection 2025.
- Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Somatropin | Protein / enzyme biologic | — | Subcutaneous |
| Subject | somapacitan | Protein / enzyme biologic | — | Subcutaneous |