Trial · NCT04541186
Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
NCT04541186, Phase 2, Completed, 89bio, Inc.; results first posted 2024-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia. Trials, record NCT04541186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04541186
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
- NCT number
- NCT04541186
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 86 participants, actual
- Lead sponsor
- 89bio, Inc.
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- Pegozafermin, Placebo
- First posted
- 2020-09-09
- Last updated
- 2024-07-25
- Results first posted
- 2024-07-25
- Limitations and caveats
- The study did not separately evaluate the response to pegozafermin in participants who were on and who were not on concurrent fibrate therapy due to small sample size in the Fibrate Expansion cohort.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 8 in Serum Triglyceride (TG) | Baseline, Week 8 | |
| Secondary | Number of Participants Who Achieved TG <500 mg/dL at Week 8 | Week 8 | |
| Secondary | Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Baseline, Week 8 | Least Squares Means were calculated using mixed-model repeated measures (MMRM). |
| Secondary | Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG | Baseline, Week 8 | |
| Secondary | Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight | Baseline, Week 8 | Least Squares Mean was calculated using MMRM. |
| Secondary | Percent Change From Baseline to Week 8 in Liver Fat as Assessed by Magnetic Resonance Imaging - Whole Liver Proton Density Fat Fraction (MRI-PDFF) | Baseline, Week 8 | Least Squares Mean was calculated using analysis of covariance (ANCOVA). |
| Secondary | Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP) | Baseline, Week 8 | |
| Secondary | Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Baseline, Week 8 | Least Squares Mean was calculated using MMRM. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Week 8 in Serum Triglyceride (TG) | Baseline, Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | MEDIAN |
| SECONDARY | Number of Participants Who Achieved TG <500 mg/dL at Week 8 | Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Baseline, Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG | Baseline, Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | MEDIAN |
| SECONDARY | Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight | Baseline, Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 8 in Liver Fat as Assessed by Magnetic Resonance Imaging - Whole Liver Proton Density Fat Fraction (MRI-PDFF) | Baseline, Week 8 | All participants in the FAS who had baseline and a follow-up MRI-PDFF assessment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP) | Baseline, Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Baseline, Week 8 | FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups. | percent change from Baseline | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 8 in Serum Triglyceride (TG) | Pegozafermin | -57.33 | Inter-Quartile Range -69.07 to -32.31 | percent change from Baseline | |
| Percent Change From Baseline to Week 8 in Serum Triglyceride (TG) | Placebo | -11.85 | Inter-Quartile Range -23.22 to 7.88 | percent change from Baseline | |
| Number of Participants Who Achieved TG <500 mg/dL at Week 8 | Pegozafermin | 51 | Participants | ||
| Number of Participants Who Achieved TG <500 mg/dL at Week 8 | Placebo | 5 | Participants | ||
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Pegozafermin | Non-HDL-C | -18.29 | Standard Error 2.943 | percent change from Baseline |
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Placebo | Non-HDL-C | -0.57 | Standard Error 5.586 | percent change from Baseline |
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Pegozafermin | ApoB | -10.51 | Standard Error 2.238 | percent change from Baseline |
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Placebo | ApoB | 1.07 | Standard Error 4.309 | percent change from Baseline |
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Pegozafermin | LDL-C | 10.44 | Standard Error 4.654 | percent change from Baseline |
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C) | Placebo | LDL-C | 8.72 | Standard Error 9.018 | percent change from Baseline |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow50
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | Pegozafermin 9 mg QW | 16 | |
| Main Study | STARTED | Pegozafermin 18 mg QW | 17 | |
| Main Study | STARTED | Pegozafermin 27 mg QW | 16 | |
| Main Study | STARTED | Pegozafermin 36 mg Q2W | 16 | |
| Main Study | STARTED | Placebo | 15 | |
| Main Study | Safety Analysis Set | Pegozafermin 9 mg QW | 12 | |
| Main Study | Safety Analysis Set | Pegozafermin 18 mg QW | 21 | |
| Main Study | Safety Analysis Set | Pegozafermin 27 mg QW | 15 | |
| Main Study | Safety Analysis Set | Pegozafermin 36 mg Q2W | 16 | |
| Main Study | Safety Analysis Set | Placebo | 15 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 participant flowAdverse events285
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 | Injection site reaction | General disorders | Pegozafermin 9 mg QW | 1 | 12 | |
| other | Injection site reaction | General disorders | Pegozafermin 18 mg QW | 2 | 21 | |
| other | Injection site reaction | General disorders | Pegozafermin 27 mg QW | 1 | 18 | |
| other | Injection site reaction | General disorders | Pegozafermin 36 mg Q2W | 2 | 16 | |
| other | Injection site reaction | General disorders | Placebo | 0 | 18 | |
| other | Injection site erythema | General disorders | Pegozafermin 9 mg QW | 0 | 12 | |
| other | Injection site erythema | General disorders | Pegozafermin 18 mg QW | 1 | 21 | |
| other | Injection site erythema | General disorders | Pegozafermin 27 mg QW | 2 | 18 | |
| other | Injection site erythema | General disorders | Pegozafermin 36 mg Q2W | 1 | 16 | |
| other | Injection site erythema | General disorders | Placebo | 0 | 18 |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegozafermin 9 mg QW | 0 | 12 |
| Total, all-cause mortality | Pegozafermin 18 mg QW | 0 | 21 |
| Total, all-cause mortality | Pegozafermin 27 mg QW | 0 | 18 |
| Total, all-cause mortality | Pegozafermin 36 mg Q2W | 0 | 16 |
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, other adverse events | Pegozafermin 9 mg QW | 7 | 12 |
| Total, other adverse events | Pegozafermin 18 mg QW | 13 | 21 |
| Total, other adverse events | Pegozafermin 27 mg QW | 13 | 18 |
| Total, other adverse events | Pegozafermin 36 mg Q2W | 7 | 16 |
| Total, other adverse events | Placebo | 9 | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37355760 | RESULT |
Source PubMed
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 |
|---|
| Pegozafermin vs Placebo: Number of Participants Who Achieved TG <500 mg/dL at Week 8 |
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/NCT04541186
GET https://conductscience.org/api/trials/v1/NCT04541186/results?page=2