Lotiglipron Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 590

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Pfizer have evaluated Lotiglipron (PF-07081532) in healthy subjects and patient populations with obesity, diabetes mellitus, and type 2 diabetes mellitus. Phase 1 studies assessed the drug's safety, tolerability, and pharmacokinetic interactions, while Phase 2 research investigated therapeutic efficacy and dose-ranging parameters. Current statuses across these trials include both completed and terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05745701	Completed	Healthy	Pfizer	2023-02-22	Phase 1
NCT05671653	Terminated	Obesity	Pfizer	2023-01-19	Phase 1
NCT05579977	Terminated	Diabetes Mellitus\|Obesity	Pfizer	2022-10-27	Phase 2
NCT05158244	Completed	Type 2 Diabetes Mellitus	Pfizer	2021-12-22	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Lotiglipron product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lotiglipron acts as a potent, orally active glucagon-like peptide-1 receptor (GLP-1R) agonist that selectively binds GLP-1R, activating intracellular cAMP downstream signaling cascades to stimulate insulin secretion and suppress glucagon release. This receptor activation enhances glucose homeostasis and satiety pathways, providing the mechanistic rationale for lowering blood glucose and reducing body weight in clinical trial conditions including 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>).