Healthy VolunteersPhase 1NCT02943239
Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
A Phase 1 study testing REGN1033 and REGN2477 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 sites in New Zealand.
Trial summary
The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033. The secondary objectives are to: Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume Assess the effects of REGN2477 alone, REGN1033 alone, and… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN1033 and REGN2477
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 8 Dec 2016to 30 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women age 45 to 70 years and age 35 to 60 years inclusive for men not intending to father children
- BMI between 18 to 32 kg/m2, inclusive
- Willing and able to maintain current diet, supplements and physical activity level throughout the study
- Provides signed informed consent
Who cannot join
- Significant illness or history of significant illness
- Contraindication to MRI
- History of human immunodeficiency virus (HIV); hepatitis B or hepatitis C virus (HCV)
- History of immobilization, major surgical procedure, fracture, or major trauma within 9 months prior to screening
- History of significant gynecological disorders or malignancies; history of breast malignancies (uterine fibroids or dysfunctional uterine bleeding is acceptable)
- Inconsistent vigorous physical activity (on fewer than 5 days per week), such as intermittent weight lifting
Show all 10Show fewer
- History of hypersensitivity reactions to tetracycline antibiotics (includes doxycycline), vaccines, or biologics
- Use of agents that alter muscle mass that have not been at a stable dose for 3 months prior to screening (includes protein supplements), or use of any weight altering or anabolic steroid drugs (includes drugs for obesity, diuretics, testosterone)
- Participants treated with a biologic therapy or biologic immunotherapy in the previous 12 weeks prior to screening and during the study
- Note: Other protocol Inclusion/Exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033.
The secondary objectives are to:
- Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume
- Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition
- Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033
- Assess immunogenicity of REGN2477 or REGN1033
- Assess REGN2477 or REGN1033 target engagement
- Conditions
- Healthy Volunteers
- Being tested
- REGN1033, REGN2477, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN1033Drug
REGN1033
REGN2477Drug
REGN2477
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Panel A | Experimental | REGN1033 + REGN2477 (Regimen 1) or placebo Receives: Drug: REGN1033; Drug: REGN2477; Other: Placebo |
| Panel B | Experimental | Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo Receives: Drug: REGN1033; Drug: REGN2477; Other: Placebo |
| Panel C | Experimental | Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo Receives: Drug: REGN1033; Drug: REGN2477; Other: Placebo |
| Panel D | Experimental | Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo Receives: Drug: REGN1033; Drug: REGN2477; Other: Placebo |
| Panel E | Experimental | REGN2477 (Regimen 5) or placebo Receives: Drug: REGN2477; Other: Placebo |
| Panel F | Experimental | REGN2477 + REGN1033 (Regimen 6) or placebo Receives: Drug: REGN1033; Drug: REGN2477; Other: Placebo |
| Panel G | Experimental | REGN2477 (Regimen 7) or placebo Receives: Drug: REGN2477; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Up to 40 weeks
Secondary outcomes (10)
Percent change in thigh muscle volume as measured by MRI
Measured: Up to 28 weeks
Change in thigh muscle volume as measured by MRI
Measured: Up to 28 weeks
Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)
Measured: Up to 28 weeks
Change in total body composition as measured by DXA
Measured: Up to 28 weeks
Change in regional body composition as measured by DXA
Measured: Up to 28 weeks
Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time
Measured: Up to 40 weeks
Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime
Measured: Up to 40 weeks
Change in total Activin A levels in blood
Measured: Up to 40 weeks
Change in total GDF8 levels in blood
Measured: Up to 32 weeks
Presence or absence of antibodies against REGN2477 and REGN1033
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start8 Dec 2016
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943239
- Sponsor's protocol ID
- R2477-1033-HV-1621
- Other IDs
- 2016-002979-95, 2016
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2016
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonzalez Trotter D, Donahue S, Wynne C, Ali S, Parasoglou P, Boyapati A, Mohammadi K, Musser BJ, Meier P, Mastaitis J, Sleeman MW, Glass DJ, Gasparino E, Trejos J, Davis JD, Hirshberg B, Pordy R, Yancopoulos GD, Herman GA. GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial. Nat Commun. 2025 May 13;16(1):4376. doi: 10.1038/s41467-025-59380-3.
PubMed 40360471
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
- ClinicalTrials.gov ID
- NCT02943239
- Acronym / sponsor ID
- R2477-1033-HV-1621
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033.
The secondary objectives are to:
- Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume
- Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition
- Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033
- Assess immunogenicity of REGN2477 or REGN1033
- Assess REGN2477 or REGN1033 target engagement
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Panel A | Experimental | Drug: REGN1033, Drug: REGN2477, Other: PlaceboREGN1033 + REGN2477 (Regimen 1) or placebo |
| Panel B | Experimental | Drug: REGN1033, Drug: REGN2477, Other: PlaceboPanel B - REGN1033 + REGN2477 (Regimen 2) or Placebo |
| Panel C | Experimental | Drug: REGN1033, Drug: REGN2477, Other: PlaceboPanel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo |
| Panel D | Experimental | Drug: REGN1033, Drug: REGN2477, Other: PlaceboPanel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo |
| Panel E | Experimental | Drug: REGN2477, Other: PlaceboREGN2477 (Regimen 5) or placebo |
| Panel F | Experimental | Drug: REGN1033, Drug: REGN2477, Other: PlaceboREGN2477 + REGN1033 (Regimen 6) or placebo |
| Panel G | Experimental | Drug: REGN2477, Other: PlaceboREGN2477 (Regimen 7) or placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women age 45 to 70 years and age 35 to 60 years inclusive for men not intending to father children
- BMI between 18 to 32 kg/m2, inclusive
- Willing and able to maintain current diet, supplements and physical activity level throughout the study
- Provides signed informed consent
Key exclusion criteria (10 listed)
- Significant illness or history of significant illness
- Contraindication to MRI
- History of human immunodeficiency virus (HIV); hepatitis B or hepatitis C virus (HCV)
- History of immobilization, major surgical procedure, fracture, or major trauma within 9 months prior to screening
- History of significant gynecological disorders or malignancies; history of breast malignancies (uterine fibroids or dysfunctional uterine bleeding is acceptable)
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 |
|---|---|---|
| REGN1033REGN1033 | Drug | Panel A, Panel B, Panel C, Panel D, Panel F |
| REGN2477REGN2477 | Drug | Panel A, Panel B, Panel C, Panel D, Panel E, Panel F, Panel G |
| PlaceboPlacebo | Other | Panel A, Panel B, Panel C, Panel D, Panel E, Panel F, Panel G |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 40 weeks
10 secondary outcomes
Percent change in thigh muscle volume as measured by MRI
Time frame: Up to 28 weeks
Change in thigh muscle volume as measured by MRI
Time frame: Up to 28 weeks
Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)
Time frame: Up to 28 weeks
Change in total body composition as measured by DXA
Time frame: Up to 28 weeks
Change in regional body composition as measured by DXA
Time frame: Up to 28 weeks
Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time
Time frame: Up to 40 weeks
Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime
Time frame: Up to 40 weeks
Change in total Activin A levels in blood
Time frame: Up to 40 weeks
Change in total GDF8 levels in blood
Time frame: Up to 32 weeks
Presence or absence of antibodies against REGN2477 and REGN1033
Time frame: Up to 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 40360471Gonzalez Trotter D, Donahue S, Wynne C, Ali S, Parasoglou P, Boyapati A, Mohammadi K, Musser BJ, Meier P, Mastaitis J, Sleeman MW, Glass DJ, Gasparino E, Trejos J, Davis JD, Hirshberg B, Pordy R, Yancopoulos GD, Herman GA. GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial. Nat Commun. 2025 May 13;16(1):4376. doi: 10.1038/s41467-025-59380-3.
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Screening Protocol
Pain
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN1033 and REGN2477 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 sites in New Zealand.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Up to 40 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 NCT02943239, 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 9 Aug 2024.