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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Does Foundayo™ (orforglipron) lead to changes in heart rate?
Treatment across orforglipron doses resulted in a mean increase in pulse rate in the phase 3 studies ATTAIN-1 and ATTAIN-2, conducted in adults with obesity or overweight without and with type 2 diabetes, respectively.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Did Orforglipron Affect Heart Rate in Phase 3 Studies for Weight Management?
- Were Adverse Events Related to Increase in Heart Rate Reported With Orforglipron?
- Enclosed Prescribing Information
- References
Did Orforglipron Affect Heart Rate in Phase 3 Studies for Weight Management?
ATTAIN-1 and ATTAIN-2 were randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of orforglipron in adults with obesity or overweight. ATTAIN-1 enrolled participants without type 2 diabetes (T2D) and ATTAIN-2 enrolled participants with T2D.1,2
These studies compared an investigational orforglipron capsule formulation with placebo during 72 weeks, plus a 2-week off-drug follow-up.1,2
This response presents safety data from the investigational orforglipron capsule formulation (1 mg, 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg) shown as equivalent doses of once-daily orforglipron tablets (0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) approved in the United States.1-3
Both ATTAIN-1 and ATTAIN-2 trials included vital sign measurements, including heart rate (measured by pulse), as part of their safety assessments.1-3
In both studies, treatment across orforglipron doses resulted in a mean increase in pulse rate.1-3
As shown in Table 1, the mean increase in pulse rate from baseline to week 72 was
- 4.3 to 5.3 beats per minute (bpm) across orforglipron doses versus 0.8 bpm with placebo in ATTAIN-1, and
- 3.0 to 4.4 bpm across orforglipron doses versus 0 bpm with placebo in ATTAIN-2.1,2
| Pulse, bpm (Normal range: 60-100 bpm) | OFG 5.5 mg | OFG 9 mg | OFG 17.2 mg | Placebo |
|---|---|---|---|---|
| ATTAIN-1 | ||||
| N | 723 | 724 | 728 | 948 |
| Baseline | 73.0 ± 0.4 | 73.0 ± 0.4 | 73.5 ± 0.4 | 73.7 ± 0.3 |
| Week 72 | 77.6 ± 0.3 | 77.9 ± 0.3 | 78.7 ± 0.3 | 74.1 ± 0.3 |
| Change at week 72 | 4.3 ± 0.3 | 4.5 ± 0.3 | 5.3 ± 0.3 | 0.8 ± 0.3 |
| ATTAIN-2 | ||||
| N | 328 | 331 | 321 | 628 |
| Baseline | 75.8 ± 0.59 | 73.7 ± 0.59 | 74.6 ± 0.60 | 74.2 ± 0.43 |
| Week 72 | 77.6 ± 0.48 | 79.0 ± 0.45 | 78.7 ± 0.49 | 74.6 ± 0.33 |
| Change at week 72 | 3.0 ± 0.48 | 4.4 ± 0.45 | 4.2 ± 0.49 | 0.0 ± 0.33 |
Data presented are model-based estimate ± standard error. N = number of participants in the safety analysis population.
Abbreviations: bpm = beats per minute; OFG = orforglipron.
Were Adverse Events Related to Increase in Heart Rate Reported With Orforglipron?
In a pool of ATTAIN-1 and ATTAIN-2, tachycardia (tachycardia, heart rate increased, and sinus tachycardia) was reported in
- 3% of patients treated with orforglipron, and
- 0.9% of patients receiving placebo.3
Treatment with orforglipron resulted in a mean increase in heart rate of 4 to 5 bpm from baseline compared to 0.5 bpm with placebo.3
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Wharton S, Aronne LJ, Stefanski A, et al; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025;393(18):1796-1806. https://doi.org/10.1056/NEJMoa2511774
- Horn DB, Ryan DH, Giljanovic Kis S, et al; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2025;406(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8.
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: April 03, 2026