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Fat LossLimited human evidence FDA-approved label on file

Orforglipron

Eli Lilly's once-daily ORAL non-peptide GLP-1 receptor agonist (LY3502970). The first oral small-molecule GLP-1 with no food/water restrictions (unlike Rybelsus). Phase 3 ACHIEVE program for diabetes and ATTAIN for obesity both ongoing.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

Phase 2 obesity (n≈272, 36 weeks): ~14.7% mean body weight reduction at the highest dose vs. ~2.3% placebo. Phase 2 diabetes trials showed HbA1c reductions comparable to injectable GLP-1s. Phase 3 ACHIEVE + ATTAIN programs ongoing; expected approval read-out late 2025 / 2026.

What's still experimental

Phase 3 data + FDA approval pending. Long-term safety, durability, and direct head-to-head vs. semaglutide / tirzepatide unknown.

Anecdotal / community reports

Some forum interest, but Orforglipron is a small-molecule (not a peptide) and is harder to access via grey-market routes than peptide GLP-1s. Most discussion is anticipatory — 'when will it ship.'

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
1 FDA-approved label on file
  • FOUNDAYO
    (ORFORGLIPRON) · Eli Lilly and Company
    Full label on DailyMed
    Indications & usage

    1 INDICATIONS AND USAGE FOUNDAYO TM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not re…

    Dosage & administration

    2 DOSAGE AND ADMINISTRATION Take FOUNDAYO orally once daily, with or without food. ( 2.1 ) Swallow tablets whole. Do not break, crush, or chew. ( 2.1 ) Do not take more than one tablet per day. ( 2.1 ) Starting dosage is 0.8 mg once daily. After at least 30 days, increase dosage to 2.5 mg once daily. ( 2.1 ) After at least 30 days on the 2.5 mg dosage, increase dosage to 5.5 mg once daily. ( 2.1 ) Dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability. ( 2.1 ) Maximum dosage is 17.2 mg once daily. ( 2.1 ) 2.1 Recommended Dosage and Administration Recommended Administration Take FOUNDAYO orally once daily, with or without food. Swallow tablets whole. Do not break, crus…

    Warnings

    5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including FOUNDAYO. Discontinue if pancreatitis is suspected. ( 5.2 ) Severe Gastrointestinal Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. FOUNDAYO is not recommended in patients with severe gastroparesis. ( 5.3 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.4 ) Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educ…

Doses studied in research

Source: Published clinical trial

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

Phase 2 trialWharton et al., NEJM 2023 (Phase 2 obesity)
Indication studied: Weight management (oral GLP-1, Phase 2/3 — not FDA-approved)
Citation: Wharton S et al., NEJM 2023
Phase 2 low
12mg(12,000 µg)
daily · oral

Lowest tested arm

Open calculator
Phase 2 mid
24mg(24,000 µg)
daily · oral

Mid-range arm

Open calculator
Phase 2 high
45mg(45,000 µg)
daily · oral

Highest tested arm — ~14.7% body weight reduction at 36 weeks

Open calculator

Notes from the source: ORAL once-daily (no injection). No food restrictions. Phase 3 ACHIEVE program ongoing.

Important framing: The numbers above are what published trials tested or what FDA-approved labels specify. They are NOT a SmartPeptide recommendation for you. Trial doses come paired with screening, monitoring, and clinician oversight. Always consult a licensed clinician before any peptide use.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
No FDA enforcement actions (recalls, market withdrawals, safety alerts) on record for “Orforglipron”. This is the expected baseline for most peptides — the absence of recalls does NOT imply general safety, only that no formal FDA enforcement has been initiated against approved formulations.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL
Formula
C96H94CaF4N20O10

Protein targets (UniProt)

  • Glucagon-like peptide 1 receptor
    P43220gene: GLP1RHomo sapiens· 463 aaReviewed

    G protein-coupled receptor for glucagon-like peptide 1 (GLP-1) (PubMed:19861722, PubMed:26308095, PubMed:27196125, PubMed:28514449, PubMed:7517895, PubMed:8216285, PubMed:8405712). Ligand binding triggers activation of a signaling cascade that leads to the activation of adenylyl cyclase and increased intracellular cAMP levels (PubMed:19861722, PubMed:26308095, PubMed:27196125, PubMed:28514449, PubMed:7517895, PubMed:8216285, PubMed:8405712). Plays a role in regulating insulin secretion in respon…

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
119
total
Human studies
67
MeSH: humans
Clinical trials
17
published
Active trials
7
48 total registered

Recent PubMed studies

Search "orforglipron OR LY3502970" on PubMed

Clinical trials (ClinicalTrials.gov)

All trials for "orforglipron"

Europe PMC — 399 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Research volume (OpenAlex topic graph)

Total works
751
all years
Last 5 years
745
recent activity
Open access
600
freely readable
OA share
80%
of all works

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Total indexed
12
all human + lab studies
Meta-analyses
0
highest evidence
Systematic reviews
1
quality-weighted
Clinical trials
0
published RCTs etc.

Most influential human studies

Ranking blends meta-analysis > systematic review > clinical trial weight with influential-citation count and recency. AI TLDRs by Semantic Scholar / Allen Institute for AI.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
157
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • Eli Lilly and Company19 works
  • National Institute on Aging1 works
  • National Institute of Diabetes and Digestive and Kidney Diseases1 works
  • NIH1 works
  • Kuwait Foundation for the Advancement of Sciences1 works
  • Eli Lilly Japan1 works

Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 4 of 4 preprints indexed by Europe PMC.

Known risks

GI side effects similar to injectable GLP-1s. Pancreatitis (rare class signal), gallbladder events, theoretical thyroid C-cell concerns (rodent finding). Cardiovascular and long-term safety still characterizing in Phase 3.

Reported side effects

Nausea, vomiting, diarrhea, constipation, decreased appetite, fatigue.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
Reports filed
1
FAERS, all years
Serious reports
0
0% of reports
Top reporting countries
  • US1

Most-reported reactions

  • Dyspepsia
    1
  • Nausea
    1

Counts from FDA Adverse Event Reporting System (FAERS). Voluntary reports — they show what was reported, not whether the drug caused the event. Many reports lack confirmation. FAERS docs

What requires medical supervision

Investigational. Patients should use FDA-approved alternatives until Orforglipron is available via prescription.

Questions for your clinician

  • Would I prefer oral over injectable GLP-1 if both were available?
  • What's the timeline for Orforglipron approval?
  • Is there a clinical trial site near me?

Editorially curated references

Discussions about Orforglipron

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