danuglipron modified release (PF-06882961 MR) / Pfizer - LARVOL DELTA

Mechanism of CX11's QD vs. Danuglipron's BID via AI-PBPK Modeling (OBESITY WEEK 2025) - "Background: CX11 and Danuglipron, two small-molecule GLP-1 receptor agonists, share ​high structural similarity but exhibit ​divergent dosing regimens (CX11: once daily; Danuglipron: twice daily). In conclusion, CX11's favorable ​PK/PD profile—characterized by ​lower clearance and ​reduced tissue distribution—underpins its ​once-daily dosing and superior efficacy compared to Danuglipron. These insights highlight the critical role of ​structural optimization and ​tissue distribution control in advancing GLP-1 therapeutics with improved safety and dosing convenience."

A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Mar 2025 | Trial primary completion date: Jun 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date

Pfizer drops obesity pill development after liver injury report (Yahoo Finance) - P1 | N=82 | NCT06567327 | N=23 | NCT06568731 | Sponsor: Pfizer | "Pfizer has terminated the development of its oral obesity candidate danuglipron after a patient on a clinical trial with the drug suffered a liver injury...Two Phase I studies (NCT06567327 and NCT06568731) met pharmacokinetic (PK) endpoints and determined a formulation and dose for danuglipron. In one of these studies, an asymptomatic patient experienced a potential drug-induced liver injury. The injury resolved after drug discontinuation; however, Pfizer has decided, based on this event, available clinical data, and recent input from regulators to discontinue the development of the drug. The therapy has been investigated in a total of 1,400 patients."

Discontinued • P1 data • Obesity

A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Pfizer | N=12 ➔ 16 | Trial completion date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

Enrollment change • Trial completion date • Trial primary completion date

A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Oct 2024 ➔ Mar 2025 | Initiation date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Trial completion date • Trial initiation date • Trial primary completion date

A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Pfizer

New P1 trial

Pfizer Advances Development of Once-Daily Formulation of Oral GLP-1 Receptor Agonist Danuglipron (Businesswire) - P1 | N=20 | NCT06153758 | Sponsor: Pfizer | "Pfizer Inc...today announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies...To date, study results have demonstrated a pharmacokinetic profile supportive of once-daily dosing. with a safety profile consistent with prior danuglipron studies including no liver enzyme elevations observed in more than 1,400 study participants."

New trial • P1 data • Metabolic Disorders • Obesity

Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Pfizer | Trial completion date: Jan 2024 ➔ May 2024 | Trial primary completion date: Jan 2024 ➔ May 2024

Trial completion date • Trial primary completion date

Pfizer (PFE) plans to announce Danuglipron Phase 2b clinical trial results at the end of the year… expected to secure at least a high single-digit market share [Google translation] (Infostock Daily) - "Danuglipron (PF-07081532), Pfizer's only clinical-stage obesity treatment candidate, is scheduled to announce the results of phase 2b clinical trials at the end of the year. The final patient intervention for weight loss rate, the primary efficacy evaluation indicator, is expected to have already been completed in mid-September."

P2b data • Trial status • Metabolic Disorders • Obesity

Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open

Pfizer Announces Topline Phase 2b Results of Oral GLP-1R Agonist, Danuglipron, in Adults with Obesity (Businesswire) - P2b | N=630 | NCT04707313 | Sponsor: Pfizer | "Pfizer Inc...today announced topline data from the Phase 2b clinical trial (NCT04707313) investigating...danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline. Twice-daily dosing of danuglipron showed statistically significant reductions from baseline in body weight for all doses, with mean reductions ranging from -6.9% to -11.7%, compared to +1.4% for placebo at 32 weeks, and -4.8% to -9.4%, compared to +0.17% for placebo at 26 weeks. Placebo-adjusted reductions in mean body weight ranged from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks....Future development of danuglipron will be focused on a once-daily formulation, with pharmacokinetic data anticipated in the first half of 2024."

P2b data • PK/PD data • Metabolic Disorders • Obesity