Evidence status · reviewed 1 August 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); its type 2 diabetes indication remains under regulatory review. 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.

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).

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

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

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

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).

Sponsor topline

ACHIEVE-5

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

In the sponsor topline, added to titrated insulin glargine, A1C change from a baseline of 8.5% at week 40 (efficacy estimand) was −1.5%, −2.1% and −1.9% for the 3 mg, 12 mg and 36 mg doses versus −0.8% with placebo. The detailed publication was not identified at this tracker’s review (NCT06109311).

Sponsor release ↗ Detailed publication pending

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 Peptides.