Adult Growth Hormone DeficiencyPhase 3NCT01909479
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
A Phase 3 study testing MOD-4023 in people with Adult Growth Hormone Deficiency, run by OPKO Health, Inc. at 1 site in Israel.
Trial summary
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023). Read more about this study
- Who is it for?
- Ages 23 to 70 years
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- MOD-4023
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the age of 23 to 70 years old at screening, inclusive
- GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
- No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
- The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
- Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
- Subject had a DXA screening and the results are interpretable according to the study plan.
Who cannot join
- Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
- Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
- History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
- Signs of intracranial hypertension at screening
- Heart insufficiency, NYHA class > 2 (Appendix B)
- History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
- History of Acromegaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product (MOD-4023) In Adult Subjects With Growth Hormone Deficiency
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- MOD-4023, Placebo
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOD-4023Drug
Individualized once weekly dose of MOD-4023
PlaceboOther
Once weekly administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| MOD-4023 | Experimental | Not described Receives: Drug: MOD-4023 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Measured: Baseline to 26 weeks
Secondary outcomes (6)
Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Measured: Baseline to 26 weeks
Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Measured: Baseline to 26 weeks
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
Measured: Baseline to 52 weeks
Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
Measured: 26 weeks to 52 weeks
Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
Measured: Baseline to 26 weeks
Change in Biochemical Marker IGF-1
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2016
- Study completionAug 2018
Why it stopped: Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909479
- Sponsor's protocol ID
- CP-4-005
- Other IDs
- 2013-000830-37
- Status last verified
- Aug 2022
- First submitted
- 24 Jul 2013
- Last updated
- 12 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fleseriu M, Biller BMK, Webb SM, Strasburger CJ, Georgescu CE, Bidlingmaier M, Wang C, Baciu I, Casanueva FF, Gilis-Januszewska A, Hart G, Manners A, Choe J, Bar-Ilan A, Carlsson M, Torre D, Taylor CT, Yuen KCJ. Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study. Pituitary. 2026 Mar 25;29(2):59. doi: 10.1007/s11102-026-01661-1.
PubMed 41879875
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product (MOD-4023) In Adult Subjects With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT01909479
- Acronym / sponsor ID
- CP-4-005
- Conditions
- Adult Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Main Study was completed. LT-OLE was discontinued as sufficient safety data has been generated.
- Enrolment
- 202 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Posted 12 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOD-4023 | Experimental | Drug: MOD-4023 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 23 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women between the age of 23 to 70 years old at screening, inclusive
- GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
- No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
- The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
- Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
Key exclusion criteria (7 listed)
- Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
- Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
- History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
- Signs of intracranial hypertension at screening
- Heart insufficiency, NYHA class > 2 (Appendix B)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOD-4023Individualized once weekly dose of MOD-4023 | Drug | MOD-4023 |
| PlaceboOnce weekly administration of placebo | Other | Placebo |
Primary outcome
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time frame: Baseline to 26 weeks
6 secondary outcomes
Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
Time frame: Baseline to 52 weeks
Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks
Time frame: 26 weeks to 52 weeks
Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Biochemical Marker IGF-1
Time frame: Baseline to 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41879875Fleseriu M, Biller BMK, Webb SM, Strasburger CJ, Georgescu CE, Bidlingmaier M, Wang C, Baciu I, Casanueva FF, Gilis-Januszewska A, Hart G, Manners A, Choe J, Bar-Ilan A, Carlsson M, Torre D, Taylor CT, Yuen KCJ. Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study. Pituitary. 2026 Mar 25;29(2):59. doi: 10.1007/s11102-026-01661-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MOD-4023 in people with Adult Growth Hormone Deficiency, run by OPKO Health, Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26 (time frame: Baseline to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.