NCT06045221 (ACHIEVE-3) is a Phase 3 clinical trial of Orforglipron in Type 2 Diabetes, sponsored by Eli Lilly and Company.

Who is sponsoring NCT06045221?

NCT06045221 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT06045221?

Interventions in NCT06045221: Orforglipron, Semaglutide.

What condition does NCT06045221 study?

NCT06045221 studies Type 2 Diabetes.

Is NCT06045221 still recruiting?

NCT06045221 is currently completed. Last updated 22 September 2025.

Last reviewed 2025-09-22 · How we verify

NCT06045221: ACHIEVE-3

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Completed Phase 3 Last updated 22 September 2025

What this trial tests

Phase 3 trial testing Orforglipron in Type 2 Diabetes in 1,698 participants. Completed in 22 August 2025.

Timeline

22 September 2023

Primary endpoint
22 August 2025

22 August 2025

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,698
Start date	22 September 2023
Primary completion	22 August 2025
Estimated completion	22 August 2025
Sites	131 locations across Japan, Mexico, Argentina, Puerto Rico, China, United States

Drugs / interventions tested

Orforglipron — full drug profile →
Semaglutide (semaglutide) — full drug profile →

Conditions studied

Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

CVOT Summit Report 2025: advances along the cardiovascular-kidney-metabolic disease continuum.
Schnell O, Agarwal A, Azizi M, Ballwieser D, et al · · 2026 · PMID 42092956 · DOI 10.1186/s12933-026-03140-0
Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial.
Rosenstock J, Yabe D, Cox D, Li J, et al · · 2026 · PMID 41765029 · DOI 10.1016/s0140-6736(26)00202-3

Verify or expand the search:

Other trials of Orforglipron

Trials testing the same drug.

NCT06824051 — A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight · Phase 1 · completed
NCT06692348 — A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants · Phase 1 · completed
NCT06704763 — A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants · Phase 1 · completed
NCT06584916 — A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With · Phase 3 · completed
NCT06440980 — A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight · Phase 1 · completed

Other recruiting trials for Type 2 Diabetes

Currently open trials in the same condition.

NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
NCT07254689 — The Food for Health Study · NA · recruiting
NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06045221 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 22 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06045221.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing