Clinical Trials

Omarigliptin (MK-3102) has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4, focusing primarily on type 2 diabetes mellitus, safety in healthy volunteers, and pharmacokinetics in chronic renal insufficiency. These studies, evaluating key outcomes such as glycemic efficacy and cardiovascular safety, have been spearheaded by industry sponsors like Merck Sharp & Dohme LLC alongside academic institutions including the British University In Egypt. Across these diverse patient populations, the overall trial landscape encompasses completed, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06449235 UNKNOWN
Type2diabetes
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders
 2024-09 PHASE4
NCT04365907 UNKNOWN
Healthy Volunteers
British University In Egypt
 2020-03-11
NCT02906709 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2016-10-17 PHASE4
NCT03362398 COMPLETED
Diabetes Mellitus, Type 2
British University In Egypt
 2017-11-20
NCT02906709 Completed
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2016-10-17 Phase 4
NCT01703208 TERMINATED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-10-05 PHASE3
NCT01755156 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2013-01-11 PHASE3
NCT01698775 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-10-02 PHASE3
NCT01814748 COMPLETED
Diabetes Mellitus
Merck Sharp & Dohme LLC
 2013-05-03 PHASE3
NCT01717313 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-12-05 PHASE3
NCT01682759 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-09-10 PHASE3
NCT01704261 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-10-18 PHASE3
NCT01841697 COMPLETED
Type 2 Diabetes
Merck Sharp & Dohme LLC
 2013-06-13 PHASE3
NCT01697592 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-10-24 PHASE3
NCT01703221 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2012-10-24 PHASE3
NCT01863667 TERMINATED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2013-07-08 PHASE3
NCT01767688 COMPLETED
Diabetes Mellitus, Type 2
Merck Sharp & Dohme LLC
 2013-01-16 PHASE1
NCT01407276 COMPLETED
Chronic Renal Insufficiency; Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2011-08-08 PHASE1
NCT01217073 COMPLETED
Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2010-10-08 PHASE2
NCT01407276 Completed
Chronic Renal Insufficiency|Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
 2011-08-08 Phase 1
NCT01088711 COMPLETED
Type 2 Diabetes (T2D)
Merck Sharp & Dohme LLC
 2010-03-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-07-16)

Check the MK-3102 (Omarigliptin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Omarigliptin functions as a potent, competitive, and reversible inhibitor of dipeptidyl peptidase-4 (DPP-4), blocking the enzymatic cleavage and degradation of active incretin hormones. By preventing incretin inactivation, it prolongs endogenous hormone signaling to stimulate glucose-dependent insulin secretion and lower elevated blood glucose levels in patients with 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>).

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