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Metabolic & weight

Orforglipron

Also called Foundayo, LY3502970

Orforglipron is a once-daily pill that activates the GLP-1 receptor, but it is a small molecule, not a peptide. It was approved by the FDA in April 2026 as Foundayo for weight management. Unlike oral semaglutide, it can be taken with or without food.

FDA-approvedApproved by the FDA for at least one use after large human trials.

All printable flashcards

Illustration only. Orforglipron is not a peptide.

Overview

Orforglipron is a once-daily pill that activates the GLP-1 receptor, but it is a small molecule, not a peptide. It was approved by the FDA in April 2026 as Foundayo for weight management. Unlike oral semaglutide, it can be taken with or without food.

How it works

Established: activates the GLP-1 receptor like peptide GLP-1 drugs, reducing appetite, slowing stomach emptying, and improving blood sugar control. Because it is a small molecule, it is absorbed as a regular pill without food or water restrictions. It is metabolized by CYP3A4, so some drug interactions matter.

What research shows

  • ATTAIN-1 phase 3 RCT (n=3,127, adults with obesity without diabetes, 72 weeks, NEJM 2025): weight change −7.5% (6 mg), −8.4% (12 mg), −11.2% (36 mg) vs −2.1% placebo (treatment-regimen estimand).
  • Label trial in adults without diabetes: −11.1% with 17.2 mg vs −2.1% placebo at week 72 (marketed tablet strengths differ from trial strengths).
  • Label trial in adults with type 2 diabetes: −9.6% with 17.2 mg vs −2.5% placebo at week 72.

Doses studied in people

Study or labelDose usedSource
FDA label, Foundayo: escalation0.8 mg once daily, then 2.5 mg, then 5.5 mg, each step at least 30 days; by mouth with or without food1
FDA label, Foundayo: further titrationMay increase to 9, 14.5, or 17.2 mg once daily (max 17.2 mg) at ≥30-day intervals based on response and tolerability1
ATTAIN-1 phase 3 RCT (n=3,127)6, 12, or 36 mg once daily by mouth (start 1 mg, increased every 4 weeks), 72 weeks2

Label tablet strengths (0.8–17.2 mg) differ numerically from trial-formulation doses (1–36 mg); use the label for approved dosing.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Weekly protocol

How the schedule looks week by week. Each chart says where it comes from: a prescribing label, a clinical trial, or a protocol commonly reported online.

Foundayo label titration

Prescribing label

One week

D1D2D3D4D5D6D7

Once daily, with or without food · Oral tablet

Dose by week

0.8 mgStarting · wk 1–4
2.5 mgwk 5–8
5.5 mgwk 9–12
9 mg (optional)wk 13–16
14.5 mg (optional)wk 17–20
17.2 mg (optional)Maximum · wk 21+
Course
Ongoing
Note
Each step needs at least 30 days on the current dose, so weeks are approximate. Steps above 5.5 mg depend on response and tolerability; maximum 17.2 mg daily.
Source
FOUNDAYO (orforglipron) prescribing information (Lilly US label, revised 07/2026)

ATTAIN-1 phase 3 trial (36 mg arm)

Clinical trial

One week

D1D2D3D4D5D6D7

Once daily · Oral tablet

Dose by week

1 mgwk 1–4
3 mgwk 5–8
6 mgwk 9–12
12 mgwk 13–16
24 mgwk 17–20
36 mgMaintenance · wk 21–72
Course
72 weeks
Note
All arms started at 1 mg with 4-week steps; the 6 mg and 12 mg arms stopped escalating at their target. Trial-formulation doses differ from the approved Foundayo tablet strengths.
Source
Wharton S et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for obesity (ATTAIN-1). N Engl J Med 2025

Reference only, not a recommendation. Label and trial schedules were set for specific patients under medical supervision. Use the calculator only to understand the arithmetic.

Safety

  • Boxed warning (label): risk of thyroid C-cell tumors; contraindicated with personal or family history of medullary thyroid carcinoma or MEN 2. Rodent tumors were not seen because the drug is not active in rodents, so human relevance is undetermined.
  • Common side effects (label): nausea (26–35% vs 10% placebo), constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, fatigue, burping, reflux, hair loss.
  • Discontinuation due to side effects: 5.3–10.3% vs 2.7% placebo in ATTAIN-1; in the label's pooled trials, 8% overall (10% at 17.2 mg) vs 3% placebo.
  • Interactions (label): limit dose to 9 mg with strong CYP3A4 inhibitors; avoid strong CYP3A4 inducers; simvastatin max 20 mg; use non-oral or barrier contraception for 30 days after starting and after each dose increase.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

Storage and stability

Per label: store tablets at room temperature.

General lab handling, not instructions for personal use. See Storage and stability.

History

Discovered by Chugai and developed by Eli Lilly. ATTAIN-1 phase 3 results were published in NEJM in September 2025. FDA approved it as Foundayo on April 1, 2026, about 50 days after filing, under the Commissioner's National Priority Voucher pilot program (original goal date was January 20, 2027).

Common questions

Is orforglipron FDA-approved?

Yes. The FDA approved it as Foundayo on April 1, 2026, for chronic weight management in adults with obesity, or with overweight plus a weight-related condition 13.

Is orforglipron a peptide like semaglutide?

No. It is a small-molecule pill that switches on the same GLP-1 receptor that peptide GLP-1 drugs use 12. Because of this, the label allows it to be taken with or without food 1.

What did the main trials show?

In the 72-week ATTAIN-1 trial of 3,127 adults with obesity but no diabetes, average weight fell 7.5% to 11.2% depending on dose, versus 2.1% on placebo 2. In the label trials, the 17.2 mg tablet gave an 11.1% loss in adults without diabetes and 9.6% in adults with type 2 diabetes 1.

What doses were studied?

The FDA label starts at 0.8 mg once daily and steps up no faster than every 30 days, to a maximum of 17.2 mg 1. ATTAIN-1 used a different trial formulation at 6, 12 or 36 mg, so those numbers do not match the marketed tablet strengths 12.

What are the side effects?

Nausea was the most common (26% to 35% versus 10% on placebo), along with constipation, diarrhea, vomiting and indigestion 1. The label has a boxed warning about thyroid C-cell tumors and rules out use with a personal or family history of medullary thyroid cancer or MEN 2 1.

Does orforglipron interact with other medicines?

Yes. It is broken down by the liver enzyme CYP3A4, so the label limits the dose with strong CYP3A4 blockers and says to avoid strong CYP3A4 inducers 1. It also advises non-oral or barrier birth control for 30 days after starting and after each dose increase 1.

Related compounds

Metabolic & weightFDA-approvedFlashcard

Semaglutide

Wegovy · Ozempic

Semaglutide is a long-acting copy of the gut hormone GLP-1.

Metabolic & weightFDA-approvedFlashcard

Liraglutide

Saxenda · Victoza

Liraglutide is an older, once-daily GLP-1 medicine.

Metabolic & weightFDA-approvedFlashcard

Tirzepatide

Zepbound · Mounjaro

Tirzepatide is a weekly shot that acts on two gut-hormone receptors, GIP and GLP-1, at once.

Sources

  1. Foundayo (orforglipron) Prescribing Information, revised 7/2026 (Drugs.com mirror of FDA label) FDA label
  2. Wharton S et al. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment (ATTAIN-1). N Engl J Med 2025 Journal
  3. FDA approves orforglipron, an oral GLP-1 for adults with obesity (Healio, Apr 1, 2026) Regulatory

Last reviewed 2026-10-25 · How we research · Found an error? See our corrections policy.