Lilly Reports Retatrutide Lowered A1C and Weight More Than Ozempic 2 mg in a Phase 3 Head-to-Head. Here Is What the Release Shows and What It Does Not
The short version
- On 28 October 2026 Eli Lilly announced topline results from TRANSCEND-T2D-2, a Phase 3, open-label trial of its investigational drug retatrutide against Ozempic 2 mg in 1,298 adults with type 2 diabetes. The figures come from Lilly's press release; the full data are not yet presented or published.
- At 80 weeks Lilly reports A1C fell by an average of 2.2% on retatrutide 9 mg and 12 mg, against 1.8% on Ozempic 2 mg, from an average baseline of 8.3%. Lilly says retatrutide met the primary and all key secondary endpoints.
- Average body weight fell 19.5% on 9 mg and 20.9% on 12 mg, against 9.4% on Ozempic 2 mg, from an average baseline of 102.4 kg (225.8 lb).
- Treatment stopped because of adverse events in 4.8% (9 mg) and 7.9% (12 mg) of participants, against 2.7% on Ozempic. Lilly lists diarrhea, nausea, constipation, vomiting and dyspepsia as the most common events. The release does not report serious adverse events or deaths.
- Lilly's figures are for the efficacy estimand, which assumes participants stayed on treatment. Lilly says its comparisons with Ozempic were controlled for family-wise type 1 error, except 9 mg superiority on A1C and on systolic blood pressure, which showed nominal significance.
- Retatrutide is not approved by any regulator. Lilly's release says it cannot be legally sold or marketed for human use, and that anyone purporting to sell it to consumers is breaking the law.
On 28 October 2026 Eli Lilly announced topline results from TRANSCEND-T2D-2, a Phase 3 trial that compared its investigational drug retatrutide with Ozempic 2 mg in adults with type 2 diabetes. Lilly says retatrutide lowered A1C more and produced more than double the weight loss at 80 weeks. These are the company's own topline figures from a press release. The full data have not been presented or published. Here is what the release says, how to read it, and what it does not change, as of 31 October 2026.
What Lilly reported
| Measure at 80 weeks | Retatrutide 9 mg | Retatrutide 12 mg | Ozempic 2 mg |
|---|---|---|---|
| Average change in A1C (average baseline 8.3%) | down 2.2% | down 2.2% | down 1.8% |
| Average change in body weight (average baseline 102.4 kg, 225.8 lb) | down 19.5% (20.1 kg, 44.3 lb) | down 20.9% (21.5 kg, 47.4 lb) | down 9.4% (9.5 kg, 20.9 lb) |
| Stopped treatment because of adverse events | 4.8% | 7.9% | 2.7% |
Source: Lilly press release of 28 October 2026 (efficacy estimand), read on 31 October 2026. Lilly describes Ozempic 2 mg as the highest approved dose of that drug.
The trial, as Lilly describes it
- 1,298 adults with type 2 diabetes inadequately controlled with metformin, with or without an SGLT2 inhibitor, and a baseline A1C of 7.0% to 10.5%.
- Randomized 2:2:1 to once-weekly retatrutide 9 mg, retatrutide 12 mg or Ozempic 2 mg. Retatrutide started at 2 mg and rose every four weeks to its target dose.
- Open-label, which means participants and investigators knew which drug was being given. Registered as NCT06260722.
- Primary objective: show that retatrutide 12 mg is noninferior to Ozempic 2 mg on A1C at 80 weeks. About 650 participants continue into a 24-week extension.
- Lilly also says it is comparing retatrutide with tirzepatide head to head in TRIUMPH-5, an ongoing Phase 3 trial in adults with obesity, with or without type 2 diabetes.
Side effects Lilly listed
| Most common events | Retatrutide 9 mg | Retatrutide 12 mg | Ozempic 2 mg |
|---|---|---|---|
| Diarrhea | 28.3% | 32.7% | 26.4% |
| Nausea | 21.2% | 23.8% | 21.3% |
| Constipation | 14.2% | 13.1% | 19.8% |
| Vomiting | 10.2% | 15.0% | 13.2% |
| Dyspepsia | 10.4% | 8.5% | 11.6% |
| Dysesthesia | 4.8% | 6.5% | 2.7% |
| Urinary tract infection | 5.8% | 4.2% | 5.8% |
Lilly says the majority of these events were mild to moderate and typically resolved during treatment. The release does not report serious adverse events or deaths from the trial, so it cannot be used to say how often they occurred.
How to read it
- It is a sponsor's topline press release. Lilly says detailed results "will be presented at a future medical meeting and published in a peer-reviewed journal". Until then nobody outside the company can check the numbers.
- All figures are for the efficacy estimand, which Lilly defines as efficacy had all randomized participants stayed on study treatment for 80 weeks, with possible dose interruptions and modifications, without starting additional glucose-lowering medication for more than 14 days. That is not the same as what happened to every participant.
- Lilly says retatrutide met the primary and all key secondary endpoints. Its endnote says all comparisons of retatrutide with Ozempic 2 mg were controlled for family-wise type 1 error, a safeguard against false positives when many comparisons are made. It lists two exceptions: superiority of retatrutide 9 mg on A1C and on systolic blood pressure, which it calls prespecified secondary endpoints that showed nominal statistical significance. In Lilly's table, the A1C result for the 12 mg dose (the dose named in the primary objective) and the weight results for both doses carry p below 0.001 against Ozempic with that control. Lilly also says A1C noninferiority of the 9 mg dose was met under the control.
- Lilly says retatrutide also delivered greater improvements than Ozempic across certain cardiovascular risk factors, including non-HDL cholesterol, triglycerides and systolic blood pressure. The release gives no figures for them.
What it does not change
- Retatrutide is not approved. Lilly's release calls it an investigational molecule that has not been approved "by FDA or any regulatory organization anywhere in the world", and says it cannot be legally sold or marketed for human use. Lilly adds: "Anyone purporting to sell retatrutide to consumers is breaking the law."
- The release does not test or analyse any product sold outside the trial, and it does not say what is in products sold online. On sales it makes two statements, both quoted above: that retatrutide cannot be legally sold or marketed for human use, and that anyone purporting to sell it to consumers is breaking the law. The trial gave Lilly's own investigational drug under a trial protocol. Our report on what the record shows about retatrutide sold outside trials is black-market retatrutide.
- The release gives no regulatory filing date.
What to watch
- The detailed TRANSCEND-T2D-2 data at a medical meeting and in a journal.
- TRIUMPH-5, the head-to-head against tirzepatide.
- Any Lilly announcement of a regulatory submission, and any FDA decision.
We will update this piece when Lilly publishes the full data. Every regulator action on peptides we have verified is in the enforcement tracker.
Questions readers ask
What did Lilly announce about retatrutide on 28 October 2026?
Lilly announced topline results from TRANSCEND-T2D-2, a Phase 3 open-label trial of retatrutide against Ozempic 2 mg in 1,298 adults with type 2 diabetes. At 80 weeks Lilly reports a 2.2% average A1C reduction on both retatrutide doses against 1.8% on Ozempic, and average weight loss of 19.5% (9 mg) and 20.9% (12 mg) against 9.4%. Lilly says retatrutide met the primary and all key secondary endpoints. Detailed results are to be presented at a medical meeting and published later.
Is retatrutide approved or legal to buy?
No. Lilly's release says retatrutide is an investigational molecule that has not been approved by the FDA or any regulatory organization anywhere in the world, and that it cannot be legally sold or marketed for human use. Lilly says anyone purporting to sell it to consumers is breaking the law.
Do these results apply to retatrutide sold online?
The release does not say what is in any product sold online. On sales it says only that retatrutide cannot be legally sold or marketed for human use and that anyone purporting to sell it to consumers is breaking the law, which is Lilly's statement. The trial gave Lilly's own investigational drug under a trial protocol, so the results say nothing about a product sold online under the same name.
Sources
- Eli Lilly: Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial (press release, PR Newswire), 28 October 2026; read 31 October 2026