glp1ledger

Foundayo Review: What the Trial Registry and the Label Show About Results, Side Effects and Who Stopped

In Foundayo's main trial, 54.5% of people on the top dose lost at least 10% of body weight at 72 weeks and 28.5% lost less than 5%; nearly one in four stopped the tablet. The posted results add the side-effect curve by dose — vomiting climbs from 13% to 24% — and the daily rule is simpler than any other GLP-1 pill's. No score, no verdict.

Ronald R · Edited by Caroline S · Published 2026-10-02

Illustration: A single, plain white pill on a soft blue ceramic saucer, illuminated by warm natural light.
Illustration

Foundayo (orforglipron) is Eli Lilly's once-daily tablet for weight management, approved by the FDA on 1 April 2026. It is the first approved GLP-1 medicine that is not a peptide — a small molecule — which is why it can be taken with food. This review reports the record a person deciding about it can check: the label's trial results as a distribution, who stopped, what the side effects looked like at each dose in the posted trial results, and the daily rule. Everything was read from the FDA label (effective 2026-07-29) and the ClinicalTrials.gov results for ATTAIN-1 on 2 October 2026.

There is no score and no verdict here. Foundayo is compared with the Wegovy pill on Foundayo vs Wegovy pill and with Lilly's injection on orforglipron vs tirzepatide; what it costs is on Foundayo cost.

One fact to know before reading any Foundayo number: the trials used an earlier formulation at 6, 12 and 36 mg, and the label reports the same arms as 5.5, 9 and 17.2 mg of the marketed tablet. The figures below use the label's strengths; GLP-1 pills cost explains the conversion.

The result, as a distribution

Averages hide how differently people respond. The label's Trial 1 — 3,127 adults with obesity, or overweight with a weight-related condition, and no diabetes — reports the share of each group reaching each threshold at week 72:

Lost at least Placebo 5.5 mg 9 mg 17.2 mg
5% of body weight 26.8% 59.6% 63.1% 71.5%
10% 13.0% 32.5% 39.8% 54.5%
15% 6.0% 14.3% 20.1% 35.9%
20% 2.9% 5.9% 8.9% 18.4%
Average change −2.1% −7.4% −8.3% −11.1%

Read the top-dose column from the bottom: about one in five lost a fifth of their weight, about half lost a tenth, and 28.5% lost less than 5% (100 − 71.5, glp1ledger arithmetic). In Trial 2, in adults with type 2 diabetes, everything is lower — the top dose averaged −9.6% against −2.5% on placebo, and 10.8% reached a 20% loss.

Why the same trial has two headline numbers

ClinicalTrials.gov's posted results for ATTAIN-1 give the top dose −12.35% and placebo −0.87%. The label gives −11.1% and −2.1%. Both are correct; they answer different questions.

  • The posted figure uses only weights measured "up to the earliest date of discontinuation of study drug" — what happened to people while they were taking it.
  • The label figure is a "treatment regimen" estimate that counts everyone randomised, including people who stopped, whose weights partly returned.

The gap between them is a rough measure of what stopping does to the average. A person reading "12%" in a news story and "11%" on a price page is not seeing a contradiction — but the label's number is the one that describes starting the drug, not staying on it.

Who stopped, and why

Placebo 5.5 mg 9 mg 17.2 mg
Stopped the trial drug before week 72 (label, Trial 1) 30% 22% 22% 24%
Stopped because of adverse reactions (label, Trials 1 + 2 pooled) 3% 6% 9% 10%
Left the study, giving lack of effect as the reason (posted) 26 of 949 2 of 723 1 of 725 0 of 730
Completed the study (posted) 80.9% 86.4% 86.9% 87.5%

Percentages in the last row: glp1ledger arithmetic from the posted participant flow.

Two things stand out. More people stopped placebo than the drug, mostly because it was not working — 26 people on placebo left the study for lack of effect, against none at the top dose. And stopping for side effects rose with dose, to one in ten at 17.2 mg; the label says most of those were gastrointestinal. Leaving the study and stopping the tablet are counted separately, which is why the two sources' figures differ.

Side effects in the trial, by dose

From ATTAIN-1's posted adverse-event table (events in at least 5% of a group), as a share of everyone who took at least one dose:

Event Placebo 6 mg (→ 5.5) 12 mg (→ 9) 36 mg (→ 17.2)
Nausea 10.4% 28.9% 35.9% 33.7%
Constipation 9.3% 21.6% 29.8% 25.4%
Diarrhoea 9.6% 21.0% 22.8% 23.1%
Vomiting 3.5% 13.0% 21.4% 24.0%
Indigestion (dyspepsia) 5.0% 13.1% 16.2% 14.1%
Belching 1.1% 6.1% 5.9% 7.6%
Serious adverse events, any 4.9% 5.5% 5.4% 3.8%

glp1ledger arithmetic from the posted counts (e.g. vomiting 175 of 728 at 36 mg).

Vomiting is the side effect that climbs most clearly with dose — nearly doubling from the lowest to the highest. Nausea and constipation peak at the middle dose. Serious adverse events were no more common on orforglipron than on placebo. How long GI episodes tend to last on this class is on GLP-1 nausea.

The label adds the class boxed warning about thyroid C-cell tumours seen in rodents — with the unusual note that orforglipron "is not pharmacologically active in rats or mice and did not produce tumors in rodents" — and the warnings shared across the GLP-1 class.

The daily rule — the part pill users live with

Foundayo's label, read as written:

  • Taken once daily, "with or without food". No empty-stomach window, no limit on water, no wait before eating.
  • Swallowed whole — "do not break, crush, or chew" — and no more than one tablet a day.
  • Missed doses: take it as soon as possible, never double up; after 7 or more consecutive missed doses, the label says to restart escalation at a lower dose to limit stomach side effects.
  • Interactions: the label lowers the maximum dose alongside strong CYP3A4 inhibitors (some antifungals and antibiotics, for example) and says to avoid strong CYP3A4 inducers. A medicines list needs checking with the prescriber or pharmacist.
  • Storage: room temperature, 20–25 °C; the tablets come in bottles with a desiccant.

This is the sharpest practical difference from the Wegovy pill, whose label requires an empty stomach, no more than 4 ounces of water and a 30-minute wait — described on the Wegovy pill review. How the two pills are absorbed, and why they differ, is on oral GLP-1.

The case against, stated plainly

  • Less weight loss on average than the injections. The label's top-dose −11.1% at 72 weeks sits below what the injectable semaglutide and tirzepatide labels report; no head-to-head trial with an injection has reported.
  • A wide spread. More than a quarter of the top-dose group lost under 5%.
  • Digestive side effects are common, and one in ten on the top dose stopped because of them.
  • A daily habit. One tablet every day; a week of missed doses means restarting lower.
  • A new drug. Approved in April 2026; the longest trial follow-up in the label is 72 weeks, and no cardiovascular-outcomes result has been posted.
  • CYP3A4 drug interactions that the injectable GLP-1s do not carry.

What is not established

  • How Foundayo compares head-to-head with the Wegovy pill or any injection. Every comparison so far sets separate trials side by side.
  • Long-term outcomes. ClinicalTrials.gov lists 53 orforglipron studies, 27 with posted results; none of the posted ones is a cardiovascular-outcomes trial.
  • What happens after stopping. The label does not report weight after discontinuation.
  • The marketed tablet in a full efficacy trial. The label's efficacy results come from the earlier formulation, presented "as equivalent dosages".

Price, in one line

Self-pay, $149 to $349 for a 30-day bottle depending on strength, with $299 at the two top doses under Lilly's refill offer, and as little as $25 with a covering commercial plan for at most 10 fills a year (read 2 October 2026) — details on Foundayo cost.

This page reports what the label and the trial registry record. It is not advice on whether to start, switch or stop any medicine; that decision belongs with the prescriber.

Sources

  • Foundayo (orforglipron) prescribing information, Eli Lilly and Company, DailyMed set ID 8ac446c5-feba-474f-a103-23facb9b5c62, effective 2026-07-29 — Dosage and Administration (2.1–2.3), Adverse Reactions (6.1), Clinical Studies (14, Table and trial discontinuation), How Supplied. Read via openFDA, 2 October 2026.
  • ClinicalTrials.gov, NCT05869903 (ATTAIN-1), posted results (first posted 2026-08-14): participant flow, primary outcome and analysis population, adverse events module. clinicaltrials.gov/study/NCT05869903, read 2 October 2026.
  • ClinicalTrials.gov, NCT05872620 (ATTAIN-2), posted results: participant flow and primary outcome. clinicaltrials.gov/study/NCT05872620, read 2 October 2026.
  • ClinicalTrials.gov API v2, intervention search "orforglipron" (53 records; 27 with posted results), 2 October 2026.

Frequently asked questions

How effective is Foundayo?

In the label's main trial in adults without diabetes, average weight loss at 72 weeks was 11.1% on the top 17.2 mg dose against 2.1% on placebo. The spread matters more than the average: 54.5% of the top-dose group lost at least 10% and 18.4% at least 20%, while 28.5% lost less than 5%. In people with type 2 diabetes (Trial 2) the top dose averaged 9.6% against 2.5%.

What are the most common Foundayo side effects?

Digestive ones. In ATTAIN-1's posted results, nausea affected 29–36% of the orforglipron groups against 10% on placebo, constipation 22–30% against 9%, diarrhoea 21–23% against 10% and vomiting 13–24% against 3.5%. Vomiting rose most clearly with dose. The label reports that 10% of people on the top dose stopped because of adverse reactions, mostly gastrointestinal, against 3% on placebo.

Do you have to take Foundayo on an empty stomach?

No. Foundayo's label says it is taken once daily 'with or without food', swallowed whole and not broken, crushed or chewed, with no more than one tablet a day. That is the main practical difference from the Wegovy pill, whose label requires an empty stomach, a small amount of water and a 30-minute wait before eating.

How many people stop taking Foundayo?

In the label's Trial 1, 24% of the top-dose group stopped the trial drug before week 72, against 30% on placebo — more people stopped placebo than the drug. Stopping because of side effects was different: across both trials 10% on the top dose stopped for adverse reactions, against 3% on placebo.

How much weight can you lose on Foundayo in a month?

The label reports results at week 72, not month by month, and the escalation to higher doses takes several months, so early weight change is smaller than the 72-week figure. The trial averages — 11.1% at the top dose over 72 weeks — are group results, and a quarter or more of participants lost under 5%. What one person loses cannot be predicted from them.

Is Foundayo worth it?

This page does not give a verdict. It reports what the trials and the label show: a smaller average weight loss than the injectable GLP-1 drugs, a simpler daily rule than the Wegovy pill, a high rate of digestive side effects, and self-pay prices of $149 to $349 a month. Whether that trade suits a person is a decision for them and their prescriber.