Clinical Trials

Orforglipron (LY3502970) is currently evaluated across numerous clinical trials spanning Phase 1 to Phase 4 development. Sponsored by major institutions including Eli Lilly and Company, Innovent Biologics, and Massachusetts General Hospital, these studies target metabolic and cardiovascular conditions—including type 2 diabetes, obesity, overweight status, chronic kidney disease, prediabetes, and obstructive sleep apnea—alongside pharmacokinetic assessments in healthy volunteers. Featuring diverse recruitment statuses (completed, recruiting, active not recruiting, and not yet recruiting), protocols range from early phase 1 bioavailability studies to late-stage phase 3 pivotal trials assessing clinical efficacy and safety.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07241390 RECRUITING
Atherosclerosis Cardiovascular Disease; Chronic Kidney Disease
Eli Lilly and Company
2025-12-01 PHASE3
NCT07729332 NOT_YET_RECRUITING
Obesity
Massachusetts General Hospital
2026-11-01 PHASE4
NCT07668336 NOT_YET_RECRUITING
Diabetes Mellitus, Type 2
Eli Lilly and Company
2026-09 PHASE3
NCT07739537 NOT_YET_RECRUITING
Diabete Type 2; Pharmacogenomic Drug Interaction
Massachusetts General Hospital
2026-10-01 PHASE4
NCT07794579 NOT_YET_RECRUITING
Overweight; Prediabetic State; Prehypertension; Obesity, Abdominal
Eli Lilly and Company
2026-09 PHASE3
NCT07223593 RECRUITING
Peripheral Arterial Disease
Eli Lilly and Company
2025-10-31 PHASE3
NCT07153471 RECRUITING
Osteoarthritis
Eli Lilly and Company
2025-09-15 PHASE3
NCT07790861 NOT_YET_RECRUITING
Obesity; Overweight
Eli Lilly and Company
2026-12 PHASE3
NCT07202884 RECRUITING
Urinary Incontinence,Stress
Eli Lilly and Company
2025-09-30 PHASE3
NCT06672939 RECRUITING
Obesity; Overweight
Eli Lilly and Company
2024-11-18 PHASE3
NCT07793019 NOT_YET_RECRUITING
Overweight; Healthy Participants; Obesity
Innovent Biologics (Suzhou) Co. Ltd.
2026-09-01 PHASE1
NCT06948435 ACTIVE_NOT_RECRUITING
Hypertension; Overweight or Obesity
Eli Lilly and Company
2025-04-30 PHASE3
NCT06952530 ACTIVE_NOT_RECRUITING
Hypertension
Eli Lilly and Company
2025-04-30 PHASE3
NCT06948422 ACTIVE_NOT_RECRUITING
Hypertension
Eli Lilly and Company
2025-04-30 PHASE3
NCT06993792 ACTIVE_NOT_RECRUITING
Obesity; Overweight; Type 2 Diabetes
Eli Lilly and Company
2025-05-15 PHASE3
NCT06972472 ACTIVE_NOT_RECRUITING
Obesity; Overweight; Type 2 Diabetes
Eli Lilly and Company
2025-05-19 PHASE3
NCT06972459 ACTIVE_NOT_RECRUITING
Obesity; Overweight
Eli Lilly and Company
2025-05-15 PHASE3
NCT07613307 RECRUITING
Diabetes Mellitus, Type 2; Diabetes Melletus; Glucose Metabolism Disorders; Metabolic Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior; Fasting; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Receptors, Peptide
Eli Lilly and Company
2026-07-15 PHASE3
NCT06672549 RECRUITING
Obesity; Overweight
Eli Lilly and Company
2024-11-18 PHASE3
NCT06649045 ACTIVE_NOT_RECRUITING
OSA; Overweight or Obesity
Eli Lilly and Company
2024-10-22 PHASE3
NCT05803421 COMPLETED
Type 2 Diabetes; Obesity; Overweight or Obesity; Overweight; Cardiovascular Diseases; Chronic Kidney Disease
Eli Lilly and Company
2023-04-03 PHASE3
NCT06824051 COMPLETED
Obesity; Overweight
Eli Lilly and Company
2025-02-17 PHASE1
NCT06584916 COMPLETED
Obesity; Overweight
Eli Lilly and Company
2024-09-13 PHASE3
NCT06192108 COMPLETED
Type 2 Diabetes
Eli Lilly and Company
2024-01-10 PHASE3
NCT06109311 COMPLETED
Type 2 Diabetes
Eli Lilly and Company
2023-11-10 PHASE3
NCT06045221 COMPLETED
Type 2 Diabetes
Eli Lilly and Company
2023-09-22 PHASE3
NCT05872620 COMPLETED
Obesity; Overweight; Type 2 Diabetes
Eli Lilly and Company
2023-06-05 PHASE3
NCT05869903 ACTIVE_NOT_RECRUITING
Obesity; Overweight; Overweight or Obesity
Eli Lilly and Company
2023-06-05 PHASE3
NCT05931380 COMPLETED
Obesity
Eli Lilly and Company
2023-07-31 PHASE3
NCT06692348 COMPLETED
Healthy
Eli Lilly and Company
2024-12-13 PHASE1
NCT06010004 COMPLETED
Type 2 Diabetes
Eli Lilly and Company
2023-09-28 PHASE3
NCT06440980 COMPLETED
Healthy; Obese; Overweight; Obesity
Eli Lilly and Company
2024-06-24 PHASE1
NCT05971940 COMPLETED
Type 2 Diabetes
Eli Lilly and Company
2023-08-09 PHASE3
NCT06704763 COMPLETED
Healthy
Eli Lilly and Company
2024-12-06 PHASE1
NCT06370728 COMPLETED
Healthy
Eli Lilly and Company
2024-05-06 PHASE1
NCT06186622 COMPLETED
Healthy; Obese; Overweight
Eli Lilly and Company
2024-01-02 PHASE1
NCT06370728 Not yet recruiting
Healthy
Eli Lilly and Company
2024-05-03 Phase 1
NCT06109311 Recruiting
Type 2 Diabetes
Eli Lilly and Company
2023-11-10 Phase 3
NCT06085482 Completed
Healthy
Eli Lilly and Company
2023-10-19 Phase 1
NCT06023095 Active not recruiting
Overweight|Obesity
Eli Lilly and Company
2023-09-21 Phase 1
NCT05936138 Completed
Renal Insufficiency|Healthy
Eli Lilly and Company
2023-07-13 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Orforglipron (LY3502970) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Orforglipron functions as a non-peptidal agonist that selectively binds and activates the glucagon-like peptide-1 receptor, triggering downstream cyclic adenosine monophosphate production and glucose-dependent insulin secretion from pancreatic beta cells. This signaling cascade suppresses postprandial glucagon release, delays gastric emptying, and reduces appetite, driving the clinical efficacy observed in trials for glycemic control in type 2 diabetes mellitus and weight reduction in 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>).

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