Adomeglivant Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Eli Lilly and Company have evaluated adomeglivant (LY2409021) in healthy volunteers, patients with type 2 diabetes mellitus, and individuals with chronic kidney failure or renal impairment. These studies assessed single-dose pharmacokinetics, formulation transitions, and cardiovascular parameters, including blood pressure and pulse rate. Across these trials, recruitment statuses encompass both completed and terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02385084	Terminated	Healthy	Eli Lilly and Company	2015-03	Phase 1
NCT02217618	Completed	Healthy Participants	Eli Lilly and Company	2014-08	Phase 1
NCT02091362	Completed	Type 2 Diabetes Mellitus	Eli Lilly and Company	2014-03	Phase 2
NCT01929109	Completed	Kidney Failure Chronic\|Renal Insufficiency Chronic	Eli Lilly and Company	2013-08	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adomeglivant acts as a potent and selective antagonist of the glucagon receptor, competitively inhibiting glucagon binding to suppress hepatic adenylate cyclase activation and subsequent intracellular cyclic AMP signaling. This downstream attenuation of glycogenolysis and gluconeogenesis reduces hepatic glucose output, thereby lowering elevated fasting blood glucose levels in clinical contexts such as type 2 diabetes mellitus.

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>).