Orforglipron

Oral non-peptide small-molecule GLP-1 receptor agonist

Obesityweight management

Orforglipron

Evidence levelLate-stage human

Human evidenceSubstantial

Regulatory statusFDA-approved product

What you need to know in 20 seconds

What is it?	Oral non-peptide small-molecule GLP-1 receptor agonist
Research focus	Obesity, weight management, type 2 diabetes, cardiometabolic risk
Human evidence	Large Phase III trials demonstrate clinically meaningful weight loss and glycaemic efficacy with oral orforglipron.
Regulatory status	FDA approved Foundayo (orforglipron) on 1 April 2026 for chronic weight management in adults with obesity, or overweight with at least one weight-related comorbidity; approval is product/indication/jurisdiction specific.
Main limitations	Use outside authorised indications, equivalence of unapproved products, or long-term outcomes beyond current evidence.
Safety	GI adverse events predominate; authorised label contains contraindications/warnings and advises against concomitant use with another GLP-1 receptor agonist.

Large Phase III trials demonstrate clinically meaningful weight loss and glycaemic efficacy with oral orforglipron.

What the evidence actually supports

✓Strong human evidence for approved indication/product; formulation conversion must be explicit.
✓This is a mandatory regulatory-status rewrite of the v4 record.
✓Separate obesity approval from diabetes trial evidence.

What is not established / key limitations

×Higher-dose tolerability caused more discontinuation; not every patient reaches headline loss.
×Approval is product-, formulation-, population- and jurisdiction-specific.
×This does not by itself define every currently authorised diabetes indication or jurisdictional status.

Selected study & evidence records

ATTAIN-1: Orforglipron for Obesity Treatment

2025 · Randomized, double-blind, placebo-controlled trial · n=3127

Weight change -7.5%, -8.4%, -11.2% across doses vs -2.1% placebo; cardiometabolic measures also improved.

Study detail → Primary source ↗

ACHIEVE-1: orforglipron in early type 2 diabetes

2025 · Randomized, double-blind, placebo-controlled trial · n=559

HbA1c fell by about 1.24-1.48 percentage points versus 0.41 with placebo; weight fell up to 7.6% versus 1.7% placebo.

Study detail → Primary source ↗

Safety and unknowns

GI adverse events predominate; authorised label contains contraindications/warnings and advises against concomitant use with another GLP-1 receptor agonist.

Gastrointestinal adverse events are common. FDA labeling includes a boxed warning regarding thyroid C-cell tumor risk context and contraindications for MTC/MEN2, plus other GLP-1-class precautions.

Technical details

Mechanism / biologySmall-molecule partial agonism at the GLP-1 receptor, designed for once-daily oral administration without peptide injection requirements.

Route / formulation boundaryCurrent labelled Foundayo tablet strengths/dose escalation must be kept separate from numeric doses used in earlier Phase III trial publications.

Identity / data-quality noteNot a peptide. Keep investigational capsule doses and approved tablet-equivalent doses distinct.

Dosing evidence statusFDA-labelled dosing and Phase 3 trial dosing verified. FDA label starts at 0.8 mg tablet daily and titrates at ≥30-day intervals; ATTAIN trials used investigational capsule doses with tablet-equivalent strengths. See dosing records.

Identifiers & alternate namesOrfor · Foundayo · LY3502970