Clinical Trials

Pfizer has sponsored numerous early-phase clinical trials evaluating the oral non-peptide GLP-1 receptor agonist danuglipron, primarily targeting type 2 diabetes mellitus and obesity. Additional clinical trials assessed the drug's pharmacokinetics and tolerability in healthy participants as well as cohorts with renal or hepatic impairment. Recruitment across this clinical portfolio includes both completed and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06910839 TERMINATED
Overweight; Obesity
Pfizer
 2025-03-13 PHASE1
NCT06567327 COMPLETED
Obesity
Pfizer
 2024-08-28 PHASE1
NCT06541678 COMPLETED
Healthy
Pfizer
 2024-12-23 PHASE1
NCT06568731 COMPLETED
Obesity
Pfizer
 2024-08-23 PHASE1
NCT06153758 COMPLETED
Healthy Participants; Healthy Subjects
Pfizer
 2023-11-27 PHASE1
NCT04707313 COMPLETED
Obesity
Pfizer
 2021-01-29 PHASE2
NCT05093205 COMPLETED
Healthy Adults
Pfizer
 2021-10-25 PHASE1
NCT04616027 COMPLETED
Diabetes Mellitus, Type 2; Renal Impairment; Healthy
Pfizer
 2021-01-13 PHASE1
NCT04889157 COMPLETED
Diabetes Mellitus, Type 2
Pfizer
 2021-07-07 PHASE1
NCT04604496 COMPLETED
Hepatic Impairment; Healthy Volunteers
Pfizer
 2020-12-30 PHASE1
NCT04617275 COMPLETED
Diabetes; Obesity
Pfizer
 2021-01-06 PHASE2
NCT04839393 COMPLETED
Healthy Volunteer
Pfizer
 2021-04-05 PHASE1
NCT04616339 COMPLETED
Overweight and/or Obesity
Pfizer
 2020-11-04 PHASE1
NCT03985293 COMPLETED
Diabetes Mellitus, Type 2
Pfizer
 2019-10-15 PHASE2
NCT04621227 COMPLETED
Obesity
Pfizer
 2020-12-15 PHASE1
NCT04552470 COMPLETED
Type 2 Diabetes Mellitus
Pfizer
 2020-10-26 PHASE1
NCT04616027 Completed
Diabetes Mellitus Type 2|Renal Impairment|Healthy
Pfizer
 2021-01-13 Phase 1
NCT04495140 COMPLETED
Healthy Volunteer
Pfizer
 2020-07-22 PHASE1
NCT04552470 Completed
Type 2 Diabetes Mellitus
Pfizer
 2020-10-26 Phase 1
NCT03538743 COMPLETED
Type 2 Diabetes Mellitus
Pfizer
 2018-06-25 PHASE1
NCT03492697 COMPLETED
Healthy Subjects
Pfizer
 2018-04-30 PHASE1
NCT03538743 Completed
Type 2 Diabetes Mellitus
Pfizer
 2018-06-25 Phase 1
NCT03309241 COMPLETED
Healthy Subjects
Pfizer
 2017-10-17 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-08-07)

Check the Danuglipron (PF-06882961) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Danuglipron (PF-06882961) functions as a selective non-peptide agonist that binds the extracellular domain of the glucagon-like peptide-1 receptor at Trp33, directly stimulating canonical G protein-mediated signaling pathways. This receptor activation enhances glucose-dependent insulin secretion and promotes satiety signaling, providing therapeutic efficacy for glycemic control and weight reduction in clinical conditions such as type 2 diabetes mellitus and obesity.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.