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Orforglipron: Trials and FDA Status

Orforglipron is a oral small-molecule glp-1. This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Also calledFoundayo
Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
FDA approved as Foundayo (1 Apr 2026)
Phase
Approved
Sponsor
Eli Lilly
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT05051579, NCT05048719, NCT05869903, NCT05872620, NCT05971940
Results

Reported results

  • 2025ATTAIN-1 phase 3 (NEJM 2025): weight change at 72 weeks vs placebo“The mean change in body weight from baseline to week 72 was -7.5% (95% confidence interval [CI], -8.2 to -6.8) with 6 mg of orforglipron, -8.4% (95% CI, -9.1 to -7.7) with 12 mg of orforglipron, and -11.2% (95% CI, -12.0 to -10.4) with 36 mg of orforglipron, as compared with -2.1% (95% CI, -2.8 to -1.4) with placebo”pubmed.ncbi.nlm.nih.gov

Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.

Timeline

Milestones

  1. Lilly reports the submission for orforglipron for type 2 diabetes in the U.S.
  2. Lilly reports U.S. FDA approval of Foundayo (orforglipron) for adults with obesity or overweight with weight-related medical problems
  3. Orforglipron approved as FoundayoApproval
  4. Lilly reports submissions for orforglipron for obesity in the U.S. and Japan, and for obesity and type 2 diabetes in the EU
  5. Published in Lancet (London, England) (2026): Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial.
  6. NCT05872620 (ATTAIN-2; Phase 3): primary completion
  7. NCT05869903 (ATTAIN-1; Phase 3): primary completion
  8. NCT05971940 (ACHIEVE-1; Phase 3): primary completion
  9. Published in The New England journal of medicine (2025): Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment.
  10. NCT05971940 (ACHIEVE-1; Phase 3): study start
  11. NCT05971940 (ACHIEVE-1; Phase 3): first posted on ClinicalTrials.gov
  12. NCT05869903 (ATTAIN-1; Phase 3): study start
  13. NCT05872620 (ATTAIN-2; Phase 3): study start
  14. NCT05872620 (ATTAIN-2; Phase 3): first posted on ClinicalTrials.gov
  15. NCT05869903 (ATTAIN-1; Phase 3): first posted on ClinicalTrials.gov
  16. Published in The New England journal of medicine (2023): Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity.
  17. NCT05048719 (A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus; Phase 2): primary completion
  18. NCT05051579 (A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities; Phase 2): primary completion
  19. NCT05051579 (A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities; Phase 2): study start
  20. NCT05051579 (A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities; Phase 2): first posted on ClinicalTrials.gov
  21. NCT05048719 (A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus; Phase 2): first posted on ClinicalTrials.gov
  22. NCT05048719 (A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus; Phase 2): study start

What people search

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US monthly searches, Google Keyword Planner, Oct 2026. Shown so you can see which questions this page answers.

Sources

  1. 1FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions (1 Apr 2026)Eli Lilly and Company (press release) · 2026investor.lilly.comAccessed 2 Oct 2026
  2. 2A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities (NCT05051579)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  3. 3A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus (NCT05048719)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  4. 4ATTAIN-1: A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (NCT05869903)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  5. 5ATTAIN-2: A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (NCT05872620)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  6. 6ACHIEVE-1: A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (NCT05971940)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  7. 7Orforglipron approved as FoundayoFDA · 2026fda.govAccessed 2 Oct 2026
  8. 8Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity.The New England journal of medicine · 2023PMID 37351564Accessed 2 Oct 2026
  9. 9Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment.The New England journal of medicine · 2025PMID 40960239Accessed 2 Oct 2026
  10. 10Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial.Lancet (London, England) · 2026PMID 41275875Accessed 2 Oct 2026
  11. 11Lilly reports submissions for orforglipron for obesity in the U.S. and Japan, and for obesity and type 2 diabetes in the EUEli Lilly (press release) · 2026sec.govAccessed 2 Oct 2026
  12. 12Lilly reports U.S. FDA approval of Foundayo (orforglipron) for adults with obesity or overweight with weight-related medical problemsEli Lilly (press release) · 2026sec.govAccessed 2 Oct 2026
  13. 13Lilly reports the submission for orforglipron for type 2 diabetes in the U.S.Eli Lilly (press release) · 2026sec.govAccessed 2 Oct 2026

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