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)
Mechanism and Biochemical Profile
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>).
- Orforglipron (LY3502970) Mechanism of Action: GLP-1R Activation in Hypothalamic Neurons Research
- Orforglipron (LY3502970) Working Concentration | Cell Culture | Treatment
- Orforglipron (LY3502970) Solubility in DMSO
- Orforglipron (LY3502970) Stock Solution
- Orforglipron (LY3502970) Storage
- Orforglipron (LY3502970) Stability
- Orforglipron (LY3502970) Combination Database
- Orforglipron (LY3502970) Molecular Weight
- Orforglipron (LY3502970) CAS Number
- Orforglipron (LY3502970) Chemical Structure (2D and 3D)
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- Orforglipron (LY3502970) SDS|MSDS