Primary outcomeMean· Week -3, week 34
Change in Truncal Fat Percentage (Week 34)
| Group | Value (Percentage of truncal fat) | Spread |
|---|---|---|
| Placebo | 0.49 | 3.31 |
| Norditropin | -2.39 | 4.48 |
| Somapacitan | -1.17 | 2.89 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataTrial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Short name REAL 1
NCTNCT02229851 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4054Other id2013-002892-16Other idU1111-1145-0211Other idJapicCTI-152767
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 301 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
19 countries
United States, Australia, Brazil, Germany, India, Israel, Japan, Latvia, Lithuania, Malaysia, Norway, Poland, Romania, Russia, South Africa, Sweden, Turkey (Türkiye), Ukraine, United Kingdom
- Start
- 31 Oct 2014
- Primary completion
- 21 Apr 2017
- Completion
- 7 May 2018
- First posted
- 3 Sept 2014 (estimated)
- Last update posted
- 23 Nov 2020
- Conditions
- Growth Hormone Disorder · Adult Growth Hormone Deficiency
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016201720182019
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- somapacitanDrug
- somatropinDrug
- placeboDrug
Arms3
Experimental
NNC0195-0092 (somapacitan)
Active comparator
Daily hGH
Placebo comparator
Placebo
Switch to NNC0195-0092 (somapacitan) treatment in the extension period.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Truncal Fat Percentage (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Secondary outcomes(20)
Change in Truncal Fat Percentage (Week 87)
Time frame · week -3, week 87
Registry description
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Truncal Fat Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Truncal Fat Mass (Week 87)
Time frame · week -3, week 87
Registry description
Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Truncal Lean Body Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Truncal Lean Body Mass (Week 87)
Time frame · week -3, week 87
Registry description
Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Total Fat Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Total Fat Mass (Week 87)
Time frame · Week -3, week 87
Registry description
Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Visceral Adipose Tissue (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Visceral Adipose Tissue (Week 87)
Time frame · Week -3, week 87
Registry description
Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Android Fat Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Android Fat Mass (Week 87)
Time frame · week -3, week 87
Registry description
Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Gynoid Fat Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Gynoid Fat Mass (Week 87)
Time frame · week -3, week 87
Registry description
Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Appendicular Skeletal Muscle Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Appendicular Skeletal Muscle Mass (Week 87)
Time frame · week -3, week 87
Registry description
Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Lean Body Mass (Week 34)
Time frame · Week -3, week 34
Registry description
Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Change in Lean Body Mass (Week 87)
Time frame · week -3, week 87
Registry description
Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Bone Mineral Content (Week 87)
Time frame · week -3, week 87
Registry description
Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in Bone Mineral Density (Week 87)
Time frame · week -3, week 87
Registry description
Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Change in IGF-I SDS (Week 34)
Time frame · Week -3, week 34
Registry description
Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· week -3, week 87
Change in Truncal Fat Percentage (Week 87)
| Group | Value (Percentage of truncal fat) | Spread |
|---|---|---|
| Placebo/Somapacitan | -2.16 | 3.94 |
| Somapacitan/Somapacitan | -1.63 | 3.65 |
| Norditropin/Norditropin | -2.63 | 4.65 |
| Norditropin/Somapacitan | -0.96 | 4.51 |
Secondary outcomeMean· Week -3, week 34
Change in Truncal Fat Mass (Week 34)
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo | 417.86 | 1536.36 |
| Norditropin | -619.67 | 1887.50 |
| Somapacitan | -180.98 | 1762.31 |
Secondary outcomeMean· week -3, week 87
Change in Truncal Fat Mass (Week 87)
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo/Somapacitan | -311.85 | 1771.78 |
| Somapacitan/Somapacitan | -196.18 | 2249.21 |
| Norditropin/Norditropin | -685.56 | 2258.93 |
| Norditropin/Somapacitan | 364.08 | 2548.85 |
Secondary outcomeMean· Week -3, week 34
Change in Truncal Lean Body Mass (Week 34)
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo | 402.69 | 1247.67 |
| Norditropin | 832.77 | 1409.74 |
| Somapacitan | 800.27 | 1377.75 |
Secondary outcomeMean· week -3, week 87
Change in Truncal Lean Body Mass (Week 87)
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo/Somapacitan | 1197.30 | 1500.56 |
| Somapacitan/Somapacitan | 1152.79 | 1480.06 |
| Norditropin/Norditropin | 975.79 | 1258.62 |
| Norditropin/Somapacitan | 1015.12 | 1554.88 |
Secondary outcomeMean· Week -3, week 34
Change in Total Fat Mass (Week 34)
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo | 305.47 | 2689.06 |
| Norditropin | -855.71 | 3167.06 |
| Somapacitan | -85.47 | 3022.71 |
Secondary outcomeMean· Week -3, week 87
Change in Total Fat Mass (Week 87)
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo/Somapacitan | -540.04 | 3250.16 |
| Somapacitan/Somapacitan | -118.07 | 3795.36 |
| Norditropin/Norditropin | -923.01 | 4099.45 |
| Norditropin/Somapacitan | 874.56 | 4789.34 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo - Main PhaseParticipants received placebo for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | 1 / 61 | 5 / 61 | 29 / 61 |
| Somapacitan - Main PhaseParticipants received somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | 0 / 120 | 7 / 120 | 53 / 120 |
| Norditropin - Main PhaseParticipants received Norditropin® for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | 1 / 119 | 12 / 119 | 55 / 119 |
| Somapacitan - Extension PhaseThe extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the following listed participants: 1) participants who received placebo in the main phase, and switched to receive somapacitan in the extension phase. 2) Participants who received somapacitan in the main phase were continued to receive somapacitan in the extension phase. 3) Participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive somapacitan in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®). | 2 / 220 | 15 / 220 | 85 / 220 |
| Norditropin- Extension PhaseThe extension phase treatment period was 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment). This reporting group shows data from the extension phase for the participants who received Norditropin® in the main phase and re-randomised at the end of the main phase to receive Norditropin® in the extension phase (randomisation was done in a 1:1 manner to receive either somapacitan and Norditropin®). | 1 / 52 | 3 / 52 | 27 / 52 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies3
Studies that cite this trial.
Studies with results
3 studies on this page
Indexing hint: Randomized controlled trial · 2025
4 results
Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial.
Otsuka et al. 2025Frontiers in endocrinologycited by 5
PMID 39991735PMC11842232DOI 10.3389/fendo.2025.1534891PUB-39991735
CC BY4 results
PubMed tag: none · 2023
10 results
Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.
Takahashi et al. 2023Pituitarycited by 12
PMID 36380045PMC9908671DOI 10.1007/s11102-022-01283-3PUB-36380045
CC BY10 results
Indexing hint: Randomized controlled trial · 2020
5 results
Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.
Johannsson et al. 2020The Journal of clinical endocrinology and metabolismcited by 65
PMID 32022863PMC7076631DOI 10.1210/clinem/dgaa049PUB-32022863
CC BY5 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 23 Years up to 79 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
* Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)
* If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
* FOR ALL COUNTRIES EXCEPT JAPAN:
Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):
1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m\^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m\^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m\^2, a peak GH less than 4 ng/mL (4 mcg/L)
3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):
a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)
Exclusion Criteria:
* Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin
* Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file
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