Evidence status · reviewed 20 October 2026

Orforglipron Phase 3 evidence tracker

One dated view of the orforglipron Phase 3 program — the ATTAIN obesity trials and the ACHIEVE type-2-diabetes trials — separating peer-reviewed results from sponsor topline readouts. Evidence state comes before headline magnitude.

Orforglipron is approved in the United States for chronic weight management (marketed as Foundayo), was registered in the UAE (approval announced 3 April 2026; the second country worldwide), was approved in Saudi Arabia by the SFDA on 2 August 2026, and was authorised in the UK by the MHRA for weight management and type 2 diabetes on 10 August 2026; its US type 2 diabetes indication remains under regulatory review. On 15 October 2026, the European Medicines Agency’s human medicines committee (CHMP) adopted a positive opinion recommending EU marketing authorisation of Foundayo (orforglipron) for weight management and type 2 diabetes in adults. EMA announced the opinion on 16 October 2026 and said it now goes to the European Commission for a decision. EMA said the weight-management recommendation rests on two studies in 4,740 adults, in which weight loss at 72 weeks was about 5% to 11% depending on dose, versus about 2% to 2.5% on placebo. This tracker is research context, not clinical or personal-use guidance.

Peer reviewed Sponsor topline Detailed publication pending

The statuses below describe the source available for each result, not an approval status or a judgment about clinical use. Each date is the paper’s first online publication.

Peer reviewed

ATTAIN-1

Adults with obesity, without diabetes · Phase 3 · 72 weeks

Published in NEJM, the 36 mg dose reduced body weight by 12.4% on the efficacy estimand and 11.2% on the primary treatment-regimen estimand at week 72, versus 0.9% and 2.1% with placebo; 59.6% of the 36 mg group lost at least 10% of body weight. The trial randomized 3,127 participants (NCT05869903). A post hoc analysis of ATTAIN-1 by Lilly researchers and academic co-authors, published online in Diabetes, Obesity and Metabolism on 17 September 2026 and announced by Lilly on 1 October 2026, modelled 10-year risk with validated risk engines. At week 72, predicted type 2 diabetes risk fell more with orforglipron than with placebo (model-based hazard ratios 0.43 to 0.55), and predicted cardiovascular disease risk also fell (hazard ratios 0.82 to 0.87 on the Framingham engine). These are modelled risk scores, not observed diabetes or cardiovascular events.

Peer-reviewed publication ↗ Trial record ↗ Peer-reviewed post hoc analysis ↗
Peer reviewed

ATTAIN-2

Adults with obesity or overweight and type 2 diabetes · Phase 3 · 72 weeks

Published in The Lancet, mean body-weight change to week 72 on the treatment-regimen estimand was −9.6% with 36 mg orforglipron versus −2.5% with placebo; on the efficacy estimand the 36 mg dose lowered weight 10.5% and reduced A1C by 1.8% from a baseline of 8.1% (n=1,613, NCT05872620).

Peer-reviewed publication ↗ Trial record ↗
Peer reviewed

ACHIEVE-1

Early type 2 diabetes managed by diet and exercise · Phase 3 · 40 weeks

Published in NEJM, estimated A1C change from a baseline of 8.0% at week 40 was −1.24%, −1.47% and −1.48% for the 3 mg, 12 mg and 36 mg doses versus −0.41% with placebo; body-weight change was −7.6% at 36 mg versus −1.7% with placebo (n=559, NCT05971940).

Peer-reviewed publication ↗ Trial record ↗
Peer reviewed

ACHIEVE-2

Type 2 diabetes on metformin, active-controlled vs dapagliflozin · Phase 3 · 40 weeks

Reported by the sponsor and subsequently published in The Lancet, A1C change from a baseline of 8.1% at week 40 (efficacy estimand) was −1.3%, −1.7% and −1.7% for the 3 mg, 12 mg and 36 mg doses versus −0.8% with dapagliflozin 10 mg; orforglipron met non-inferiority then superiority (n=962, NCT06192108).

Peer-reviewed publication ↗ Trial record ↗
Peer reviewed

ACHIEVE-3

Type 2 diabetes on metformin, head-to-head vs oral semaglutide · Phase 3 · 52 weeks

Published in The Lancet, A1C change from a baseline of 8.3% at week 52 was −1.71% (12 mg) and −1.91% (36 mg orforglipron) versus −1.23% and −1.47% for oral semaglutide 7 mg and 14 mg; orforglipron met non-inferiority then superiority, and the 36 mg dose cut weight 9.2% versus 5.3% with semaglutide 14 mg (n=1,698, NCT06045221).

Peer-reviewed publication ↗ Trial record ↗
Peer reviewed

ACHIEVE-4

Type 2 diabetes with higher cardiovascular risk, vs insulin glargine · Phase 3 · open-label, event-driven cardiovascular safety

Published in The Lancet (Klein et al.), MACE-4 occurred in 4.2% of orforglipron and 5.0% of insulin glargine participants over a median of 2 years (HR 0.84; 95% CI 0.59–1.20), meeting the prespecified non-inferiority test; superiority was not shown. Lilly reported a MACE-3 HR of 0.77 (95% CI 0.52–1.13) (n=2,749, NCT05803421).

Peer-reviewed publication ↗ Trial record ↗ Sponsor release ↗
Peer reviewed

ACHIEVE-5

Type 2 diabetes added to titrated insulin glargine · Phase 3 · 40 weeks

Published online in JAMA on 7 June 2026 (Giorgino et al.; print issue 4 August 2026), added to titrated insulin glargine, A1C change from a baseline of 8.5% at week 40 was −1.58%, −1.88% and −1.82% for the 3 mg, 12 mg and 36 mg doses versus −0.79% with placebo, and body weight changed −2.6%, −4.8% and −5.4% versus +0.2%, without more clinically significant hypoglycaemia than placebo. The sponsor’s efficacy-estimand topline had reported −1.5%, −2.1% and −1.9% versus −0.8% (n=546, NCT06109311).

Peer-reviewed publication ↗ Trial record ↗ Sponsor release ↗
Peer reviewed

ATTAIN-MAINTAIN

Weight maintenance after switching from injectable tirzepatide or semaglutide · Phase 3b · 52 weeks

Published in Nature Medicine (Aronne et al.), adults who had reached a weight plateau on tirzepatide or semaglutide in SURMOUNT-5 were randomised to orforglipron or placebo; at week 52, on the treatment-regimen estimand, they kept 74.7% (after tirzepatide) and 79.3% (after semaglutide) of their prior weight loss versus 49.2% and 37.6% with placebo (n=376, NCT06584916).

Peer-reviewed publication ↗ Trial record ↗

How to read this tracker

Source strength is not interchangeable.

Peer reviewed

A full report has passed journal review and exposes methods and analyses for scrutiny.

Sponsor topline

A primary-source company release is available, but the complete paper may not yet be published.

Trial record

The registry establishes design and status; it does not substitute for a results publication.

Continue the evidence trail

See where Orforglipron sits in the wider incretin pipeline, then check the sister approval tracker on Remy Research.

Obesity drug pipeline 2026 Is Orforglipron approved? ↗ Evidence updates