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This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly [QW] or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in participants with severe hypertriglyceridemia (SHTG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegozafermin 9 mg QW | Experimental | Participants received pegozafermin 9 mg QW as an SC injection for 8 weeks in the Main Study cohort. |
|
| Pegozafermin 18 mg QW | Experimental | Participants received pegozafermin 18 mg QW as an SC injection for 8 weeks in the Main Study cohort. |
|
| Pegozafermin 27 mg QW | Experimental | Participants received pegozafermin 27 mg QW as an SC injection for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion pegozafermin 27 mg QW groups were pooled together due to low sample size in the expansion cohort. |
|
| Pegozafermin 36 mg Q2W | Experimental | Participants received pegozafermin 36 mg Q2W as an SC injection for 8 weeks in the Main Study cohort. |
|
| Placebo | Placebo Comparator | Matching placebo was injected at matching frequency per assigned cohort for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion placebo groups were pooled together due to low sample size in the expansion cohort. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegozafermin | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 8 in Serum Triglyceride (TG) | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved TG <500 mg/dL at Week 8 | Week 8 | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 89Bio Clinical Study Site | La Mesa | California | 91942 | United States | ||
| 89Bio Clinical Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37355760 | Result | Bhatt DL, Bays HE, Miller M, Cain JE 3rd, Wasilewska K, Andrawis NS, Parli T, Feng S, Sterling L, Tseng L, Hartsfield CL, Agollah GD, Mansbach H, Kastelein JJP; ENTRIGUE Principal Investigators. The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial. Nat Med. 2023 Jul;29(7):1782-1792. doi: 10.1038/s41591-023-02427-z. Epub 2023 Jun 24. |
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As per the Statistical Analysis Plan (SAP), since a low number of participants enrolled in the fibrate cohort (3 on placebo and 3 on active treatment [pegozafermin]), participants in the pegozafermin 27 mg QW fibrate cohort were combined with the pegozafermin 27 mg QW main cohort, forming a pooled pegozafermin 27 mg QW group for analyses. Similarly, the placebo participants in the fibrate cohort were combined with the main placebo group (pooled) for analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pegozafermin 9 mg QW | Pegozafermin 9 mg QW was administered as a subcutaneous (SC) injection. |
| FG001 | Pegozafermin 18 mg QW | Pegozafermin 18 mg QW was administered as an SC injection. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Main Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2021 | May 7, 2024 |
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|
|
| Placebo | Drug | Matching placebo |
|
Least Squares Means were calculated using mixed-model repeated measures (MMRM).
| Baseline, Week 8 |
| Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG | Baseline, Week 8 |
| Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight | Least Squares Mean was calculated using MMRM. | Baseline, Week 8 |
| Percent Change From Baseline to Week 8 in Liver Fat as Assessed by Magnetic Resonance Imaging - Whole Liver Proton Density Fat Fraction (MRI-PDFF) | Least Squares Mean was calculated using analysis of covariance (ANCOVA). | Baseline, Week 8 |
| Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP) | Baseline, Week 8 |
| Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Least Squares Mean was calculated using MMRM. | Baseline, Week 8 |
| San Francisco |
| California |
| 94158 |
| United States |
| 89Bio Clinical Study Site | Clearwater | Florida | 33756 | United States |
| 89Bio Clinical Study Site | Greenacres City | Florida | 33467 | United States |
| 89Bio Clinical Study Site | Jacksonville | Florida | 32205 | United States |
| 89Bio Clinical Study Site | Miami | Florida | 33125 | United States |
| 89Bio Clinical Study Site | Miami | Florida | 33135 | United States |
| 89Bio Clinical Study Site | Miami Lakes | Florida | 33014 | United States |
| 89Bio Clinical Study Site | Miami Lakes | Florida | 33016 | United States |
| 89Bio Clinical Study Site | North Miami Beach | Florida | 33162 | United States |
| 89Bio Clinical Study Site | Orlando | Florida | 32825 | United States |
| 89Bio Clinical Study Site | Tampa | Florida | 33606 | United States |
| 89Bio Clinical Study Site | Lawrenceville | Georgia | 30044 | United States |
| 89Bio Clinical Study Site | Quincy | Illinois | 62301 | United States |
| 89Bio Clinical Study Site | Wauconda | Illinois | 60084 | United States |
| 89Bio Clinical Study Site | West Des Moines | Iowa | 50266 | United States |
| 89Bio Clinical Study Site | Louisville | Kentucky | 40213 | United States |
| 89Bio Clinical Study Site | Olive Branch | Mississippi | 38654 | United States |
| 89Bio Clinical Study Site | Albany | New York | 12203 | United States |
| 89Bio Clinical Study Site | Greensboro | North Carolina | 27408 | United States |
| 89Bio Clinical Study Site | Morganton | North Carolina | 28655 | United States |
| 89Bio Clinical Study Site | Marion | Ohio | 43303 | United States |
| 89Bio Clinical Study Site | Summerville | South Carolina | 29435 | United States |
| 89Bio Clinical Study Site | Chattanooga | Tennessee | 37421 | United States |
| 89Bio Clinical Study Site | Kingsport | Tennessee | 37660 | United States |
| 89Bio Clinical Study Site | Austin | Texas | 78705 | United States |
| 89Bio Clinical Study Site | Dallas | Texas | 75204 | United States |
| 89Bio Clinical Study Site | Dallas | Texas | 77365 | United States |
| 89Bio Clinical Study Site | Houston | Texas | 77089 | United States |
| 89Bio Clinical Study Site | Lampasas | Texas | 76550 | United States |
| 89Bio Clinical Study Site | Magnolia | Texas | 77355 | United States |
| 89Bio Clinical Study Site | Manassas | Virginia | 20110 | United States |
| 89Bio Clinical Study Site | Pardubice | 530 02 | Czechia |
| 89Bio Clinical Study Site | Prague | 100 00 | Czechia |
| 89Bio Clinical Study Site | Prague | 14021 | Czechia |
| 89Bio Clinical Study Site | Prague | 150 00 | Czechia |
| 89Bio Clinical Study Site | Prague | 158 00 | Czechia |
| 89Bio Clinical Study Site | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| 89Bio Clinical Study Site | Baja | Hungary |
| 89Bio Clinical Study Site | Békéscsaba | 5600 | Hungary |
| 89Bio Clinical Study Site | Budapest | 1032 | Hungary |
| 89Bio Clinical Study Site | Debrecen | 4032 | Hungary |
| 89Bio Clinical Study Site | Bialystok | 15-351 | Poland |
| 89Bio Clinical Study Site | Bialystok | 15-879 | Poland |
| 89Bio Clinical Study Site | Lodz | 93-338 | Poland |
| 89Bio Clinical Study Site | Oświęcim | 32-600 | Poland |
| 89Bio Clinical Study Site | Rzeszów | 35-055 | Poland |
| 89Bio Clinical Study Site | Torun | 87-100 | Poland |
| FG002 | Pegozafermin 27 mg QW | Pegozafermin 27 mg QW was administered as an SC injection. |
| FG003 | Pegozafermin 36 mg Q2W | Pegozafermin 36 mg Q2W was administered as an SC injection. |
| FG004 | Placebo | Matching placebo was injected at matching frequency per assigned cohort. |
|
| Safety Analysis Set | Participants who received at least 1 dose of study drug. Safety Analysis Set is summarized based treatment received. |
|
| Full Analysis Set (FAS) | Participants who received at least 1 dose of study drug, had a baseline, and at least 1 post-baseline triglyceride measurement not including end of study (EOS) visit. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Fibrate Expansion Study |
|
|
Safety Analysis Set: All participants who received at least 1 dose of study drug. Participants are summarized by treatment received.
As per SAP, since a low number of participants enrolled in the fibrate cohort, participants randomized to pegozafermin 27 mg QW fibrate cohort were combined with the pegozafermin 27 mg QW main cohort, forming a pooled pegozafermin 27 mg QW group for analyses. Similarly, the placebo participants in the fibrate cohort were combined with the main placebo group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegozafermin 9 mg QW | Pegozafermin 9 mg QW was administered as a SC injection. |
| BG001 | Pegozafermin 18 mg QW | Pegozafermin 18 mg QW was administered as an SC injection. |
| BG002 | Pegozafermin 27 mg QW | Pegozafermin 27 mg QW was administered as an SC injection. The Main Study cohort and Fibrate Expansion cohort for pegozafermin 27 mg were pooled together due to low sample size in the expansion cohort. |
| BG003 | Pegozafermin 36 mg Q2W | Pegozafermin 36 mg Q2W was administered as an SC injection. |
| BG004 | Placebo | Matching placebo was injected at matching frequency per assigned cohort. Main Study cohort and Fibrate Expansion cohort for placebo were pooled together due to low sample size in the expansion cohort. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Triglyceride (TG) Level | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline to Week 8 in Serum Triglyceride (TG) | 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. | Posted | Median | Inter-Quartile Range | percent change from Baseline | Baseline, Week 8 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved TG <500 mg/dL at 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. | Posted | Count of Participants | Participants | Week 8 |
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| 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) | Least Squares Means were calculated using mixed-model repeated measures (MMRM). | 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. | Posted | Least Squares Mean | Standard Error | percent change from Baseline | Baseline, Week 8 |
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| Secondary | Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG | 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. | Posted | Median | Inter-Quartile Range | percent change from Baseline | Baseline, Week 8 |
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| Secondary | Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight | Least Squares Mean was calculated using MMRM. | 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. | Posted | Least Squares Mean | Standard Error | percent change from Baseline | Baseline, Week 8 |
|
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| 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) | Least Squares Mean was calculated using analysis of covariance (ANCOVA). | 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. | Posted | Least Squares Mean | Standard Error | percent change from Baseline | Baseline, Week 8 |
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| Secondary | Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP) | 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. | Posted | Median | Inter-Quartile Range | percent change from Baseline | Baseline, Week 8 |
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| Secondary | Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Least Squares Mean was calculated using MMRM. | 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. | Posted | Least Squares Mean | Standard Error | percent change from Baseline | Baseline, Week 8 |
|
|
Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled.
Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pegozafermin 9 mg QW | Pegozafermin 9 mg QW was administered as a SC injection. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG001 | Pegozafermin 18 mg QW | Pegozafermin 18 mg QW was administered as an SC injection. | 0 | 21 | 0 | 21 | 13 | 21 |
| EG002 | Pegozafermin 27 mg QW | Pegozafermin 27 mg QW was administered as an SC injection. The Main Study cohort and Fibrate Expansion cohort for pegozafermin 27 mg were pooled together due to low sample size in the expansion cohort. | 0 | 18 | 1 | 18 | 13 | 18 |
| EG003 | Pegozafermin 36 mg Q2W | Pegozafermin 36 mg Q2W was administered as an SC injection. | 0 | 16 | 0 | 16 | 7 | 16 |
| EG004 | Placebo | Matching placebo was injected at matching frequency per assigned cohort. Main Study cohort and Fibrate Expansion cohort for placebo were pooled together due to low sample size in the expansion cohort. | 0 | 18 | 0 | 18 | 9 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Entrigue Study Team | 89bio, Inc. | 1-415-432-9270 | Ct.gov_SHTG@89bio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2022 | May 2, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Not Reported |
|
| Unknown |
|
| ≥750 mg/dL |
|
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| Participants |
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