- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
PHARMACOKINETIC AND PHARMACODYNAMIC INTERACTION OF OBETICHOLIC ACID AND BEZAFIBRATE IN HEALTHY VOLUNTEERS () - Oct 15, 2024 - Abstract #AASLD2024AASLD_3119;
BZF increased total OCA plasma levels with high variability, while OCA had a slight effect on BZF levels. Together, they reduced C4 to a larger extent than either alone at a low dose of OCA, suggesting potential incremental benefit of their combination on reducing BA synthesis compared with OCA alone.
- |||||||||| Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Enrollment open, Trial primary completion date: To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate (clinicaltrials.gov) - Oct 4, 2024
P3, N=133, Enrolling by invitation,
Together, they reduced C4 to a larger extent than either alone at a low dose of OCA, suggesting potential incremental benefit of their combination on reducing BA synthesis compared with OCA alone. Not yet recruiting --> Enrolling by invitation | Trial primary completion date: Jan 2025 --> Jan 2029
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Trial completion date, Trial primary completion date, Combination therapy: Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (clinicaltrials.gov) - Jul 3, 2024
P2, N=60, Active, not recruiting,
OCA/B400 SR induced biochemical remission in 66.7% of pts and induced the greatest change in GLOBE ( Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Aug 2024 --> Nov 2024
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Trial completion date, Trial primary completion date, Combination therapy: Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC (clinicaltrials.gov) - Apr 17, 2024
P2, N=72, Active, not recruiting,
Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Aug 2024 --> Nov 2024 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Phase classification, Combination therapy: Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (clinicaltrials.gov) - Apr 7, 2024
P2, N=60, Active, not recruiting,
Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Oct 2025 Phase classification: P2a --> P2
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
METABOLIC OUTCOMES AND KEY EFFICACY DATA FROM A PHASE 2 TRIAL EVALUATING COMBINATION OBETICHOLIC ACID AND BEZAFIBRATE IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS (202A - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_2111;
Introduction : Obeticholic acid (OCA), a potent farnesoid X receptor agonist, is indicated as a second-line treatment for patients (pts) with primary biliary cholangitis (PBC) who have an inadequate response or intolerance to ursodeoxycholic acid...Conclusions : The short-term administration of OCA and BZF has therapeutic potential to normalize multiple key serum biomarkers of PBC-related liver damage that have been correlated with improved transplant-free and decompensation-free survival. Combination OCA and BZF therapy has an acceptable metabolic profile, which includes a positive impact on total cholesterol and LDL-C.
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Enrollment closed, Combination therapy: Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (clinicaltrials.gov) - Aug 7, 2023
P2a, N=60, Active, not recruiting,
Combination OCA and BZF therapy has an acceptable metabolic profile, which includes a positive impact on total cholesterol and LDL-C. Recruiting --> Active, not recruiting
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Enrollment closed, Combination therapy: Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC (clinicaltrials.gov) - Aug 7, 2023
P2, N=72, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Trial completion date, Trial primary completion date, Combination therapy: Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC (clinicaltrials.gov) - Apr 25, 2023
P2a, N=60, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jan 2023 --> Aug 2024
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Trial completion date, Trial primary completion date, Combination therapy: Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC (clinicaltrials.gov) - Feb 27, 2023
P2, N=75, Recruiting,
Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Jan 2023 --> Aug 2024 Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Oct 2024
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Trial completion date, Trial primary completion date, Combination therapy: Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC (clinicaltrials.gov) - Sep 29, 2022
P2, N=75, Recruiting,
Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Oct 2024 Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jul 2022 --> Sep 2023
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Trial completion date, Trial primary completion date, Combination therapy: Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC (clinicaltrials.gov) - May 6, 2021
P2, N=72, Recruiting,
Trial completion date: Jun 2023 --> Sep 2024 | Trial primary completion date: Jul 2022 --> Sep 2023 Trial completion date: Feb 2023 --> Jun 2023 | Trial primary completion date: Mar 2022 --> Jul 2022
- |||||||||| Ocaliva (obeticholic acid) / Intercept, Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
New P2 trial, Combination therapy: Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC (clinicaltrials.gov) - Oct 19, 2020
P2, N=72, Recruiting,
- |||||||||| Bezalip SR (bezafibrate) / AbbVie, Intercept, Miravo
Preclinical, Journal: The PPAR pan-agonist bezafibrate ameliorates cardiomyopathy in a mouse model of Barth syndrome. (Pubmed Central) - Mar 3, 2018
Thus, we demonstrate that bezafibrate has a potent therapeutic effect on preventing cardiac dysfunction in a mouse model of Barth syndrome with obvious implications for treating the human disease. Additional studies are needed to assess the potential benefits of PPAR agonists in humans with Barth syndrome.
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