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Foundayo: Orforglipron's Doses, Trial Results and Side Effects

Foundayo is orforglipron, a daily GLP-1 tablet approved in April 2026. What the label says about dosing, why the trial doses carry different numbers, and what side effects the trials recorded.

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Evidence
Evidence on Orforglipron for weight
Large trials1 randomized trial of 1,000 or more people cited here for weight.
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By Leah GarnerPublished

Foundayo is orforglipron, a GLP-1 receptor agonist taken as one tablet a day. The FDA approved it on April 1, 2026, under NDA 220934. [2] It is a small molecule rather than a peptide, and the label puts its absolute bioavailability at 77% after a 0.8 mg dose [1].

This page covers what the label says and what the trials behind it recorded, including the side effects. The molecule itself, and how it acts on the same receptor as the injections, is covered in the guide linked above.

What the FDA approved

The approval covers one use: with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term. [2] It applies to adults with obesity, or adults with overweight and at least one weight-related condition.

The label adds one limit. It does not recommend taking Foundayo alongside another GLP-1 receptor agonist [1]. Unlike the Wegovy label, it makes no claim about heart attacks or strokes.

How the label doses it

The label’s starting dose is 0.8 mg once a day [1]. After at least 30 days it rises to 2.5 mg, then after another 30 days to 5.5 mg. From there it may rise to 9 mg, 14.5 mg and 17.2 mg, each after at least 30 days, based on response and tolerability.

The maximum is 17.2 mg a day, one tablet, swallowed whole [1]. The label says it can be taken with or without food. If 7 or more daily doses in a row are missed, it says to restart the climb at a lower dose.

That food rule is the practical difference from the oral semaglutide tablet. The Wegovy pill must be taken on an empty stomach with a small amount of water, then a 30-minute wait. For Foundayo, the label reports that food lowered drug exposure by 19% in one study, which it judged not clinically relevant [1].

0.8 mg

starting dose, once daily

Foundayo label

17.2 mg

maximum dose, once daily

Foundayo label

29–49 h

elimination half-life after an oral dose

Foundayo label

Why the trial doses have different numbers

Anyone reading the trial papers will see doses of 6, 12 and 36 mg [3]. Those refer to an investigational formulation used in the trials.

The label presents the same trial groups as 5.5, 9 and 17.2 mg of Foundayo, which it calls equivalent dosages [1]. The group sizes match: 329, 332 and 322 people in the diabetes trial, in both the journal paper and the label [4] [1]. So a trial’s “36 mg” result describes the label’s 17.2 mg dose, not a dose more than twice as high.

What the two trials found

ATTAIN-1 randomized 3,127 adults with obesity or overweight, without diabetes, for 72 weeks [3] [1]. On the label’s analysis, weight fell 7.4%, 8.3% and 11.1% on the three doses, against 2.1% on placebo [1]. The journal paper, using its own estimate, reports 7.5%, 8.4% and 11.2%.

On the top dose, 54.5% lost at least 10% of their weight, against 13% on placebo, per the label [1]. The trial population averaged 103.2 kg at the start and was 64% women.

ATTAIN-2 enrolled 1,613 adults with type 2 diabetes and a BMI of 27 or more [4]. Weight loss was smaller: 5.1%, 7.0% and 9.6% across the doses, against 2.5% on placebo. HbA1c, the long-term blood sugar measure, also improved on every dose.

Neither trial compared Foundayo with an injection. How the injected drugs compare with each other is set out in tirzepatide vs semaglutide.

Orforglipron side effects

The label pools both trials: 3,155 adults on the drug for up to 72 weeks [1]. Stomach and bowel effects dominate. They were reported by 60%, 68% and 69% on the three doses, against 37% on placebo.

On the 17.2 mg dose, nausea affected 35%, diarrhea 25%, vomiting 24% and constipation 24% [1]. The placebo figures were 10%, 11%, 4% and 9%. The label says nausea, vomiting and diarrhea were more common while the dose was being raised, then eased.

Overall, 8% of people on Foundayo stopped it for side effects, against 3% on placebo [1]. Among those who reported stomach effects, 60% had mild ones and 4% severe ones.

35% vs 10%

nausea on 17.2 mg vs placebo

Foundayo label, Table 1

69% vs 37%

any gastrointestinal effect on 17.2 mg vs placebo

Foundayo label

8% vs 3%

stopped for side effects, all doses vs placebo

Foundayo label

Less common effects the label records

  • Hair loss: 7% of women and 0.9% of men on the drug, against 3% and 0.7% on placebo. The label links it to weight loss [1].
  • Heart rate: a mean rise of 4 to 5 beats per minute, against 0.5 on placebo. Fast heart rate was reported in 3%, against 0.9% [1].
  • Low blood pressure: 2% against 0.5%, rising to 4% in people also taking blood pressure medicine [1].
  • Pancreatitis: confirmed in 6 people on the drug and 1 on placebo, which the label expresses as 0.14 and 0.04 patients per 100 years of exposure [1].
  • Low blood sugar in the diabetes trial: 2% against 0.2%, and 7% among those also taking a sulfonylurea [1].

The liver has been checked separately. A pooled analysis of seven phase 3 trials, 6,920 people on orforglipron, found no case that met the criteria for drug-induced liver injury [5]. Most of its authors work for the drug’s maker, and the analysis was sponsor-run.

Switching from an injection

ATTAIN-MAINTAIN tested whether the tablet could hold weight off after an injection [6]. It took people who had lost weight on tirzepatide or semaglutide in an earlier trial and randomized them to orforglipron or placebo for 52 weeks.

Coming off tirzepatide, people on orforglipron kept an estimated 74.7% of their lost weight, against 49.2% on placebo [6]. Coming off semaglutide, the figures were 79.3% and 37.6%. The authors note the trial had no group that simply stayed on the injection, and it lasted one year.

What happens to weight when a GLP-1 drug stops altogether is covered in what happens when you stop taking semaglutide.

What this means

Foundayo is a daily tablet with a monthly dose climb and no fasting rule. In its trial without diabetes, the top dose averaged about 9 points more weight loss than placebo over 72 weeks.

Its side effects look like the rest of the class, led by nausea during the dose climb. Approved in April 2026, it has a short record outside trials. For other options with trial data, start at the weight goal page, or compare the two older injections in liraglutide vs semaglutide.

Frequently asked questions

What is Foundayo?
Foundayo is the brand name for orforglipron, a once-daily GLP-1 receptor agonist tablet. The FDA approved it on April 1, 2026, with diet and exercise, to reduce excess body weight in adults with obesity, or overweight plus a weight-related condition.
What are the side effects of orforglipron?
Mostly stomach and bowel effects. On the 17.2 mg dose, nausea affected 35% against 10% on placebo, with diarrhea, vomiting and constipation close behind. The label also records hair loss, a heart rate rise of 4 to 5 beats per minute, and rare pancreatitis.
What is the Foundayo dosage?
The label starts at 0.8 mg once daily, then 2.5 mg and 5.5 mg, each after at least 30 days. It may then rise to 9 mg, 14.5 mg and 17.2 mg, the maximum, based on response and tolerability.
Do you have to take Foundayo on an empty stomach?
No. The label says it can be taken with or without food, which differs from the Wegovy pill's empty-stomach rule.
Why do the trials say 36 mg when the label says 17.2 mg?
The trials used an investigational formulation dosed at 6, 12 and 36 mg. The label presents the same trial groups as 5.5, 9 and 17.2 mg of Foundayo, which it calls equivalent dosages.

Sources

6 cited
  1. 1U.S. Food and Drug Administration (2026). FOUNDAYO (orforglipron) tablets, for oral use: prescribing information (revised July 2026) Drugs@FDA. Source
  2. 2U.S. Food and Drug Administration (2026). NDA 220934 approval letter: Foundayo (orforglipron) tablets Drugs@FDA (April 1, 2026). Source
  3. 3Wharton S, Aronne LJ, Stefanski A, Alfaris NF, Ciudin A, Yokote K, et al. (2025). Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment New England Journal of Medicine. PMID 40960239
  4. 4Horn DB, Ryan DH, Kis SG, Alves B, Mu Y, Kim SG, et al. (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 Lancet. PMID 41275875
  5. 5Wharton S, Stefanski A, Chen J, Rao G, Twum EA, Denning M (2026). Hepatic Safety of Orforglipron in Adults With Obesity or Overweight and/or Type 2 Diabetes: A Pooled Analysis of the Orforglipron Phase 3 Clinical Trials Diabetes, Obesity and Metabolism. PMID 42338042
  6. 6Aronne LJ, Horn DB, le Roux CW, Chao AM, Ho W, Halpern B, et al. (2026). Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial Nature Medicine. PMID 42120723

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