Trial · NCT04159415
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
NCT04159415, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2025-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy. Trials, record NCT04159415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04159415
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
- NCT number
- NCT04159415
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Generalized Lipodystrophy
- Interventions
- Placebo, Low-Dose REGN4461, High-dose REGN4461
- First posted
- 2019-11-12
- Last updated
- 2026-06-15
- Other registries' IDs
- eudract:2019-000614-11
- Results first posted
- 2025-02-25
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8 | Baseline, Week 8 | Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported |
| Primary | Absolute Change From Baseline in Fasting Glucose at Week 8 | Baseline, Week 8 | Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported |
| Primary | Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8 | Baseline, Week 8 | Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported |
| Primary | Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8 | Baseline, Week 8 | Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported |
| Secondary | Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8 | Baseline, Week 8 | The composite score is calculated for each individual participant using baseline and Week 8 measurements of HbA1c and fasting TG. For each participant, a Z-score is calculated separately for HbA1c and fasting TG, rescaling the change from baseline based on the standard deviation of the baseline value for all participants, as a way of standardizing the change value. The composite score uses one or both of the calculated Z-scores depending on which parameters were abnormal at baseline. If both, then the participant's composite is the average of the two parameter Z-scores. At the participant level, a Z-score of zero for either parameter indicates no change in that metabolic parameter, but a composite Z-score of zero can also reflect offsetting changes in metabolic parameters. A negative Z-score would be interpreted as an overall improvement in metabolic function, but a negative Z-score can also result from a decrease in one parameter not being canceled by an increase in the other. |
| Secondary | Absolute Change From Baseline in Fasting Glucose | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting TG | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Absolute Change From Baseline in HbA1c | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8 | Baseline, Week 8 | Subgroup of participants with baseline HbA1c ≥ 7% or TG ≥ 250 mg/dL | Z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change From Baseline in Fasting Glucose | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | Number Analyzed equals number of participants analyzed at each time point | mg/dL | MEAN |
| SECONDARY | Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | Number Analyzed equals number of participants analyzed at each time point | mg/dL | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | Number Analyzed equals number of participants analyzed at each time point | Percentage of change | MEAN |
| SECONDARY | Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | Number Analyzed equals number of participants analyzed at each time point | Percentage of change | MEAN |
| SECONDARY | Absolute Change From Baseline in HbA1c | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52 | Number Analyzed equals number of participants analyzed at each time point | Percentage of HbA1c | MEAN |
| SECONDARY | Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52 | Number Analyzed equals number of participants analyzed at each time point | Percentage of HbA1c | MEAN |
| SECONDARY | Absolute Change From Baseline in Weighted Mean Glucose (WMG) | Baseline, Weeks 16 and 24 | Number Analyzed equals number of participants analyzed at each time point | mg/dL | MEAN |
| SECONDARY | Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7% | Baseline, Weeks 16 and 24 | Number Analyzed equals number of participants analyzed at each time point | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT) | Baseline, Weeks 8, 16, 24 | Number Analyzed equals number of participants analyzed at each time point | mg/dL*minutes | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8 | Treatment Sequence A: DBTP 1: | 0.0 | Standard Error 0.2 | Z-score | |
| Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8 | Treatment Sequence B: DBTP 1 | 0.1 | Standard Error 0.3 | Z-score | |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence A | Week 16 | -29.4 | Standard Deviation 59.80 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence B | Week 16 | -22.0 | Standard Deviation 47.85 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence A | Week 24 | -68.8 | Standard Deviation 58.74 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence B | Week 24 | -21.1 | Standard Deviation 82.85 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence A | Week 36 | -47.6 | Standard Deviation 71.04 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence B | Week 36 | 12.5 | Standard Deviation 119.63 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence A | Week 52 | -55.1 | Standard Deviation 77.97 | mg/dL |
| Absolute Change From Baseline in Fasting Glucose | Treatment Sequence B | Week 52 | 6.9 | Standard Deviation 68.64 | mg/dL |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow170
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence A, DBTP 1: Placebo SC QW | 8 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence B, DBTP 1: Low-dose REGN4461 SC QW | 8 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence A, DBTP 2: Low-dose REGN4461 SC QW | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence B, DBTP 2: Medium-dose REGN4461 SC QW | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence A, DBTP 3: Medium-dose REGN4461 SC QW | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence B, DBTP 3: Medium-dose REGN4461 SC QW | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence A, OLTP 4: Medium-dose REGN4461 SC QW | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence B, OLTP 4: Medium-dose REGN4461 SC QW | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence A, OLTP 5: High-dose | 0 | |
| Double-blind Treatment Period (DBTP) 1 | STARTED | Treatment Sequence B, OLTP 5: High-dose | 0 |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 participant flowAdverse events1,910
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Treatment Sequence A: DBTP 1 | 1 | 8 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence B: DBTP 1 | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence A: DBTP 2 | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence B: DBTP 2 | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence A: DBTP 3 | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence B: DBTP 3 | 1 | 8 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence A: OLTP 4 | 1 | 8 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence B: OLTP 4 | 0 | 8 | 0 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence A: OLTP 5 | 0 | 6 | 0 |
| other | Constipation | Gastrointestinal disorders | Treatment Sequence B: OLTP 5 | 0 | 4 | 0 |
1 to 10 of 1,910Source ClinicalTrials.gov
See all 1,910 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Sequence A: DBTP 1 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence B: DBTP 1 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence A: DBTP 2 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence B: DBTP 2 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence A: DBTP 3 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence B: DBTP 3 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence A: OLTP 4 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence B: OLTP 4 | 0 | 8 |
| Total, all-cause mortality | Treatment Sequence A: OLTP 5 | 0 | 6 |
| Total, all-cause mortality | Treatment Sequence B: OLTP 5 | 0 | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Treatment Sequence A vs Treatment Sequence B: Number of Participants With Anti-drug Antibodies (ADA) to REGN4461 |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04159415
GET https://conductscience.org/api/trials/v1/NCT04159415/registered?page=2