Healthy VolunteersPhase 1NCT03530514
A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers
A Phase 1 study testing REGN4461 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to: Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile Estimate… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN4461
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Apr 2018to 27 Jan 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A:
- Males and females 18 to 50 years of age, inclusive
- Body mass index (BMI) from 18.5 to <30.0 kg/m^2
- Participant is judged by the investigator to be in good health and free from major comorbidities based on medical history, physical examination, laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
- Part B:
- Males and females 18 to 65 years of age, inclusive
- Have a body mass index (BMI) from 25.0 to 40.0 kg/m^2
- Participant is judged by the investigator to be free from major comorbidities based upon medical history, physical examination, laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug. Participants can have a history of mild hyperlipidemia and/or mild hypertension but should be on stable doses of lipid lowering or blood pressure lowering medicines for at least 2 months prior to screening
Who cannot join
- Part A:
- History of type 1 or 2 diabetes or prediabetes or with fasting blood glucose (FBG) at screening ≥ 100mg/dL or with HbA1c at screening of ≥ 5.7%.
- Fasting LDL-C ≥ 130mg/dL, TG ≥ 250 mg/dL
- Part B:
- History of type 1 or 2 diabetes or with FBG at screening ≥ 126 mg/dL or with HbA1c at screening of ≥ 6.5%. A diagnosis of "pre-diabetes" is allowed.
- Fasting LDL-C ≥ 160 or TG ≥ 500 mg/dL
Show all 20Show fewer
- Hospitalization (ie, >24 hours) for any reason within 60 days of the screening visit
- History of hypothalamic amenorrhea or lipodystrophy.
- Change in body weight of more than 5% over the past 3 months prior to screening.
- Previous history of bariatric procedures for obesity (eg, sleeve gastrectomy, gastric bypass, banding, etc).
- Procedures for weight reduction (eg, liposuction) or body contouring in the past 6 months.
- Treatment with medications for (over-the-counter [OTC] or prescribed) weight loss (eg, lorcaserin, phentermine/topiramate, naltrexone HCl/bupropion HCl, liraglutide) in the past 3 months.
- History of major psychiatric disorders, eating disorders (eg, bulimia, anorexia).
- Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening.
- History of recreational drug (including marijuana) or alcohol abuse (>2 drinks per day) within a year prior to the screening visit.
- History of hepatitis B infection or a positive hepatitis B surface antigen (HbsAg+) at screening
- History of HIV infection or HIV seropositive at the screening visit.
- History of hepatitis C infection or positive hepatitis C antibody test result at screening.
- Pregnant or breastfeeding women.
- Note: Other inclusion/ exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, And Pharmacodynamics of Single and Multiple Doses of REGN4461 in Healthy Subjects
The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to:
- Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile
- Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in overweight and obese participants
- Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight and obese participants
- Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of lipid-regulating proteins levels over time
- Assess the immunogenicity of single and repeated doses of REGN4461
Read the detailed description
This is a 2-part study of the safety, tolerability, PK and pharmacodynamic (PD) of single and repeated doses of REGN4461 in healthy participants. In Part A, healthy lean or overweight participants will be enrolled to evaluate the safety, tolerability, PK, and PD of single ascending intravenous (IV) and subcutaneous (SC) doses. Interim PK and safety information from Part A will be used to select the dose level, frequency, and mode of administration (IV or SC) for repeat dosing in Part B. In Part B, overweight/obese participants with body mass index (BMI) 25-40 kg/m2 will be enrolled to evaluate the safety, tolerability, PK, and PD of repeated doses of REGN4461 in 4 distinct cohorts defined by baseline leptin levels.
- Conditions
- Healthy Volunteers
- Being tested
- REGN4461, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN4461Drug
REGN4461
PlaceboDrug
Placebo-matching REGN4461
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single dose cohort 1 | Experimental | Cohort 1 will receive a single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 2 | Experimental | Cohort 2 will receive a sequential ascending single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 3 | Experimental | Cohort 3 will receive a sequential ascending single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 4 | Experimental | Cohort 4 will receive a sequential ascending single SC dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 5 | Experimental | Cohort 5 will receive a sequential ascending single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 6 | Experimental | Cohort 6 will receive a sequential ascending single SC dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 7 | Experimental | Cohort 7 will receive a sequential ascending single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 8 | Experimental | Cohort 8 will receive a single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part A: Single dose cohort 9 | Experimental | Cohort 9 will receive a single IV dose of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
| Part B: Repeated dose cohort 10 | Experimental | Cohort 10 will receive repeated IV or SC doses of REGN4461 or matching placebo Receives: Drug: REGN4461; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events (TEAEs)
Measured: Up to week 27
Secondary outcomes (14)
Concentrations of REGN4461 in serum over time
Measured: Up to week 27
Percent change from baseline to week 12 in body weight in overweight or obese participants
Measured: Baseline to week 12
Absolute change from baseline to week 12 in body weight in overweight or obese participants
Measured: Baseline to week 12
Change from baseline in caloric intake in response to standardized meals in overweight or obese participants
Measured: Baseline to week 12
Change in lipid-regulating protein levels over time after single doses of REGN4461
Measured: Up to week 16
Change in lipid-regulating protein levels over time after repeated doses of REGN4461
Measured: Up to week 27
Incidence of anti-drug antibodies to REGN4461 over time after single doses of REGN4461
Measured: Up to week 16
Incidence of anti-drug antibodies to REGN4461 over time after repeated doses of REGN4461
Measured: Up to week 27
Pharmacokinetic (PK) parameter: Area under curve (AUC) computed from time zero to the time of the last positive concentration (AUClast)
Measured: Up to week 27
PK parameter: AUC computed across a dosing interval with length τ (AUCo-τ)
Measured: Upt to week 27
PK parameter: peak concentration (Cmax)
Measured: Up to week 27
PK parameter: time to Cmax (tmax)
Measured: Up to week 27
PK parameter: clearance (CL)
Measured: Up to week 27
PK parameter: trough concentration (Ctrough)
Measured: Up to week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start24 Apr 2018
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 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
- NCT03530514
- Sponsor's protocol ID
- R4461-HV-1794
- Other IDs
- 2018-000327-14, 2018
- Status last verified
- Nov 2019
- First submitted
- 7 May 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, And Pharmacodynamics of Single and Multiple Doses of REGN4461 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03530514
- Acronym / sponsor ID
- R4461-HV-1794
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 21 May 2018 (actual)
- 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 of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to:
- Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile
- Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in overweight and obese participants
- Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight and obese participants
- Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of lipid-regulating proteins levels over time
- Assess the immunogenicity of single and repeated doses of REGN4461
Detailed description
This is a 2-part study of the safety, tolerability, PK and pharmacodynamic (PD) of single and repeated doses of REGN4461 in healthy participants. In Part A, healthy lean or overweight participants will be enrolled to evaluate the safety, tolerability, PK, and PD of single ascending intravenous (IV) and subcutaneous (SC) doses. Interim PK and safety information from Part A will be used to select the dose level, frequency, and mode of administration (IV or SC) for repeat dosing in Part B. In Part B, overweight/obese participants with body mass index (BMI) 25-40 kg/m2 will be enrolled to evaluate the safety, tolerability, PK, and PD of repeated doses of REGN4461 in 4 distinct cohorts defined by baseline leptin levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A: Single dose cohort 1 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 1 will receive a single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 2 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 2 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 3 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 3 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 4 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 4 will receive a sequential ascending single SC dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 5 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 5 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 6 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 6 will receive a sequential ascending single SC dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 7 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 7 will receive a sequential ascending single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 8 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 8 will receive a single IV dose of REGN4461 or matching placebo |
| Part A: Single dose cohort 9 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 9 will receive a single IV dose of REGN4461 or matching placebo |
| Part B: Repeated dose cohort 10 | Experimental | Drug: REGN4461, Drug: PlaceboCohort 10 will receive repeated IV or SC doses of REGN4461 or matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females 18 to 50 years of age, inclusive
- Body mass index (BMI) from 18.5 to <30.0 kg/m^2
- Participant is judged by the investigator to be in good health and free from major comorbidities based on medical history, physical examination, laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
- Males and females 18 to 65 years of age, inclusive
- Have a body mass index (BMI) from 25.0 to 40.0 kg/m^2
Key exclusion criteria (20 listed)
- History of type 1 or 2 diabetes or prediabetes or with fasting blood glucose (FBG) at screening ≥ 100mg/dL or with HbA1c at screening of ≥ 5.7%.
- Fasting LDL-C ≥ 130mg/dL, TG ≥ 250 mg/dL
- History of type 1 or 2 diabetes or with FBG at screening ≥ 126 mg/dL or with HbA1c at screening of ≥ 6.5%. A diagnosis of "pre-diabetes" is allowed.
- Fasting LDL-C ≥ 160 or TG ≥ 500 mg/dL
- Hospitalization (ie, >24 hours) for any reason within 60 days of the screening visit
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 |
|---|---|---|
| REGN4461REGN4461 | Drug | Part A: Single dose cohort 1, Part A: Single dose cohort 2, Part A: Single dose cohort 3, Part A: Single dose cohort 4, Part A: Single dose cohort 5, Part A: Single dose cohort 6, Part A: Single dose cohort 7, Part A: Single dose cohort 8, Part A: Single dose cohort 9, Part B: Repeated dose cohort 10 |
| PlaceboPlacebo-matching REGN4461 | Drug | Part A: Single dose cohort 1, Part A: Single dose cohort 2, Part A: Single dose cohort 3, Part A: Single dose cohort 4, Part A: Single dose cohort 5, Part A: Single dose cohort 6, Part A: Single dose cohort 7, Part A: Single dose cohort 8, Part A: Single dose cohort 9, Part B: Repeated dose cohort 10 |
Primary outcome
Number of treatment-emergent adverse events (TEAEs)
Time frame: Up to week 27
14 secondary outcomes
Concentrations of REGN4461 in serum over time
Time frame: Up to week 27
Percent change from baseline to week 12 in body weight in overweight or obese participants
Time frame: Baseline to week 12
Absolute change from baseline to week 12 in body weight in overweight or obese participants
Time frame: Baseline to week 12
Change from baseline in caloric intake in response to standardized meals in overweight or obese participants
Time frame: Baseline to week 12
Change in lipid-regulating protein levels over time after single doses of REGN4461
Time frame: Up to week 16
Change in lipid-regulating protein levels over time after repeated doses of REGN4461
Time frame: Up to week 27
Incidence of anti-drug antibodies to REGN4461 over time after single doses of REGN4461
Time frame: Up to week 16
Incidence of anti-drug antibodies to REGN4461 over time after repeated doses of REGN4461
Time frame: Up to week 27
Pharmacokinetic (PK) parameter: Area under curve (AUC) computed from time zero to the time of the last positive concentration (AUClast)
Time frame: Up to week 27
PK parameter: AUC computed across a dosing interval with length τ (AUCo-τ)
Time frame: Upt to week 27
PK parameter: peak concentration (Cmax)
Time frame: Up to week 27
PK parameter: time to Cmax (tmax)
Time frame: Up to week 27
PK parameter: clearance (CL)
Time frame: Up to week 27
PK parameter: trough concentration (Ctrough)
Time frame: Up to week 27
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 Mar 2020.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN4461 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in Belgium.
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 8 inclusion and 20 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 Mar 2020. 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 Belgium. 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?
Number of treatment-emergent adverse events (TEAEs) (time frame: Up to week 27). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2020.