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GLP-1 receptor agonist (non-peptide small molecule)

Orforglipron

Orforglipron is a once-daily GLP-1 receptor agonist tablet from Eli Lilly, sold as Foundayo, and it is a small molecule rather than a peptide like semaglutide.

Medical review in progressLast reviewed

US regulatory status

FDA-approved prescription drug

The FDA approved orforglipron as Foundayo tablets (Eli Lilly) on April 1, 2026, for long-term weight management in adults with obesity, or with overweight and at least one weight-related condition, together with diet and exercise. Weight management is its only approved use: it has been studied in type 2 diabetes, but blood-sugar control is not on the label. Foundayo is the only FDA-approved orforglipron product; compounded or “research” versions are not FDA-approved and have not been reviewed for safety, effectiveness or quality.

As of

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On this page
  1. US regulatory status
  2. At a glance
  3. What the research shows
  4. Side effects and safety
  5. Questions people ask
  6. Sources
  7. Related compounds

At a glance

Also known as
Foundayo, LY3502970, Orforglipron calcium
Supplied as
Tablet taken by mouth
Research
Strong human evidence
US status
US status: FDA-approvedchecked

What the research shows

Evidence grade

Strong human evidence

Consistent results from large randomized controlled trials in people.

Two 72-week, placebo-controlled phase 3 trials supported the approval. In ATTAIN-1 (3,127 adults with obesity and no diabetes), average weight change was −7.5% to −11.2% across the doses tested, compared with −2.1% on placebo, with improvements in waist size, blood pressure and blood fats. In ATTAIN-2 (1,613 adults with excess weight and type 2 diabetes), it was −5.1% to −9.6%, compared with −2.5% on placebo, and HbA1c also fell. In type 2 diabetes trials, orforglipron lowered HbA1c more than placebo (ACHIEVE-1) and more than oral semaglutide in an open-label trial (ACHIEVE-3), where it also caused more stomach side effects and more people stopped treatment because of side effects. In ACHIEVE-4, in adults with type 2 diabetes and heart or kidney disease, orforglipron met the trial’s non-inferiority goal against insulin glargine for major heart events (4.2% vs 5.0% of participants over a median of 2 years). Eli Lilly funded all of these trials.

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How we grade evidence

  1. Strong human evidence · this page

    Consistent results from large randomized controlled trials in people.

  2. Limited human evidence

    Some studies in people, but they are small, short, early-phase or uncontrolled.

  3. Mixed evidence

    Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.

  4. Animal or lab studies only

    Studied in cells or animals, not properly in people. Animal results may not apply to humans.

The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.

Side effects and safety

On the Foundayo label, the most common side effects are nausea, constipation, diarrhea, vomiting, indigestion, stomach pain, headache, bloating, tiredness, burping, reflux, gas and hair loss. Nausea affected 26% to 35% of people on Foundayo in the main trials, compared with 10% on placebo, and was most frequent while the dose was being increased. Foundayo carries a boxed warning about thyroid C-cell tumors: other GLP-1 medicines caused them in rodents, orforglipron did not (it is not active in rats or mice), and the human relevance is unknown. It must not be used by people with a personal or family history of medullary thyroid carcinoma or MEN 2. Other warnings include pancreatitis, severe stomach and bowel reactions, kidney injury from dehydration, low blood sugar with insulin or sulfonylureas, serious allergic reactions, diabetic eye complications, gallbladder disease and aspiration during anesthesia or deep sedation. Heart rate rose by an average of 4 to 5 beats per minute.

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Questions people ask

Is orforglipron FDA-approved, and what is its brand name?

Yes. The FDA approved orforglipron on April 1, 2026, under the brand name Foundayo, made by Eli Lilly. It is approved for long-term weight management in adults with obesity, or with overweight and at least one weight-related condition, together with diet and exercise. As of October 16, 2026, it is not approved to treat type 2 diabetes, and Foundayo is the only FDA-approved orforglipron product.

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Is orforglipron a peptide?

No. Orforglipron is a small-molecule, “nonpeptide” drug: unlike a peptide, it is not a chain of amino acids, yet it binds to and activates the human GLP-1 receptor. Semaglutide and tirzepatide, by contrast, are modified peptides. Because it is a small molecule, orforglipron is made as an ordinary tablet; there is no vial to mix and nothing to inject.

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What are the side effects of orforglipron?

Mostly digestive. On the Foundayo label, nausea, constipation, diarrhea, vomiting, indigestion and stomach pain lead the list, followed by headache, tiredness, burping, reflux, gas and hair loss. In the two main trials, 3% to 6% of people on Foundayo stopped because of digestive side effects, compared with 0.7% on placebo. Hair loss was reported in 7% of women on Foundayo, compared with 3% on placebo. Tell your prescriber about severe or lasting stomach pain or vomiting.

Source

What did the orforglipron clinical trials show?

The two main phase 3 programs are ATTAIN and ACHIEVE, both funded by Eli Lilly. ATTAIN tested weight management: in ATTAIN-1 (NCT05869903), adults without diabetes lost an average of 7.5% to 11.2% of body weight over 72 weeks across the doses tested, compared with 2.1% on placebo. ACHIEVE tested type 2 diabetes, including ACHIEVE-4, a heart-outcomes trial against insulin glargine. In ATTAIN-MAINTAIN, people who switched from tirzepatide or semaglutide injections kept more of their weight loss on orforglipron than on placebo over 52 weeks.

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Does orforglipron have to be taken on an empty stomach?

No. The Foundayo label says to take it once daily “with or without food” and to swallow the tablet whole without breaking, crushing or chewing it. Its half-life is about 29 to 49 hours. Because it slows stomach emptying, the label advises people on birth-control pills to switch to a non-oral method or add a barrier method for 30 days after starting and after each dose increase. Store it at room temperature. Your dose and schedule come from your prescriber.

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How does orforglipron compare with semaglutide and tirzepatide?

All three act on the GLP-1 receptor, and tirzepatide also acts on GIP. Orforglipron is a daily tablet and a small molecule; semaglutide and tirzepatide are peptides. In ACHIEVE-3, an open-label trial in type 2 diabetes funded by Lilly, orforglipron lowered HbA1c more than oral semaglutide but caused more digestive side effects and more people stopped treatment. Comparing weight loss across separate trials is unreliable because the people and methods differ.

Sources

Sources

  1. FOUNDAYO (orforglipron) tablets, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  2. Drugs@FDA: NDA 220934, FOUNDAYOU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  3. FDA Approves First New Molecular Entity Under National Priority Voucher ProgramU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  4. Novel Drug Approvals for 2026U.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  5. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  6. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity TreatmentN Engl J Med, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  7. 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 trialLancet, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  8. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 DiabetesN Engl J Med, 2025 · Accessed Oct 16, 2026 (opens in a new tab)
  9. 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 trialLancet, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  10. Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trialLancet, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  11. The pharmacological basis for nonpeptide agonism of the GLP-1 receptor by orforglipronSci Transl Med, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
  12. WEGOVY (semaglutide) injection and tablets, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  13. ZEPBOUND (tirzepatide) injection, prescribing informationDailyMed, U.S. National Library of Medicine, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  14. A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1), NCT05869903ClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
  15. Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trialNat Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)

Related compounds

Guides

Medical review in progressLast reviewed

Every medical and regulatory statement on this page links to a checkable source, listed above. Peptinote does arithmetic and education, not medical advice, and never sells or links to sellers of peptides.

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