Retatrutide vs CagriSema: which comes first? Trials, FDA timeline and safety

Verdict: Retatrutide has the larger trial weight loss, 25.0% at 80 weeks [Human RCT, n=2,339]. CagriSema produced 20.4% at 68 weeks [Human RCT, n=3,417] and is closer to market, with an FDA decision due in Q4 2026. Neither drug is approved, and no trial has compared them directly.

In CagriSema vs retatrutide, each option leads on something different. Retatrutide, Eli Lilly’s once-weekly triple-hormone injection, produced the strongest single-trial result. In the phase 3 TRIUMPH-1 trial, adults without diabetes lost 25.0% of body weight on the highest dose, against 3.9% on placebo. CagriSema, Novo Nordisk’s amylin-plus-semaglutide pairing, produced 20.4% against 3.0% in REDEFINE 1. It is also about a year ahead on the regulatory clock. Novo filed its New Drug Application on 2025-12-18 and restated on 2026-10-20 that a decision is expected in Q4 2026. Lilly plans to submit retatrutide in the first quarter of 2027. Until then, both remain investigational. The FDA says retatrutide and cagrilintide “have not been found safe and effective for any condition” and “cannot be used in compounding under federal law”. Outside clinical trials and Lilly’s pre-approval expanded-access program for retatrutide, there is no legal US supply of either.

Item Retatrutide (Lilly) CagriSema (Novo Nordisk)
US FDA status Investigational; not approved for any use (FDA) Investigational; NDA under FDA review since 2025-12-18 (Novo)
Next regulatory step BLA submission planned Q1 2027 (Lilly 8-K, 2026-08-05); Q3 report of 2026-10-29 gave no new date US decision expected Q4 2026, restated 2026-10-20 (Novo); no decision as of 2026-10-31
Compounding (503A/503B) “Cannot be used in compounding under federal law” (FDA) Cagrilintide “cannot be used in compounding under federal law” (FDA)
WADA 2026 List Not named; S0 Non-Approved Substances appears to apply, prohibited at all times (WADA, our reading) Cagrilintide: same S0 reading while unapproved; semaglutide alone is not prohibited (USADA)
WADA 2027 List (from 2027-01-01) S0 now names “peptides” in general; no change for retatrutide (USADA) No change; semaglutide stays on the Monitoring Program, not prohibited (USADA)
Strongest evidence Human RCT, phase 3 (n=2,339) Human RCT, phase 3 (n=3,417)
Human trials 33 ClinicalTrials.gov records; phase 3 published: NCT05929066, NCT05929079, NCT06354660 31 ClinicalTrials.gov records; phase 3 with results: NCT05567796, NCT05394519, NCT06131437
Last checked 2026-10-31 2026-10-31
Strongest evidence: Retatrutide (Lilly): RCT; CagriSema (Novo Nordisk): RCT. US FDA status: Investigational; not approved for any use / Investigational; NDA under FDA review since 2025-12-18. WADA 2026 List: Not named; S0 Non-Approved Substances appe
Drawn from the status box above, last checked 2026-10-31.

What changed (November 2026): the sleep apnea results now come from the two dedicated phase 3 trials published in the NEJM on 2026-10-21, and CagriSema’s REIMAGINE 5 result against tirzepatide 5 mg is added.

Key points:

  • CagriSema missed its goal against tirzepatide. In REDEFINE 4 it produced 23.0% weight loss against 25.5% with tirzepatide 15 mg at 84 weeks, so it did not show non-inferiority [Human RCT, open-label, n=809].
  • Retatrutide’s only head-to-head result so far comes from TRANSCEND-T2D-2 (2026-10-28). Adults with type 2 diabetes lost 19.5% to 20.9% of body weight on retatrutide against 9.4% on Ozempic 2 mg over 80 weeks [Human RCT, open-label, topline, n=1,298].
  • Only retatrutide has phase 3 results for sleep apnea and knee osteoarthritis pain. Sleep apnea comes from two dedicated trials, TRIUMPH-1-OSA and TRIUMPH-2-OSA (NEJM 2026) [Human RCT, n=243 and n=448]; knee pain from a group inside TRIUMPH-1 [Human RCT subgroup, n=574].
  • A network meta-analysis of 58 trials ranked retatrutide ahead of CagriSema for placebo-adjusted weight loss, but the confidence intervals overlapped.
  • Neither drug has heart-outcome results yet. CagriSema’s REDEFINE 3 trial enrolled 7,076 adults with cardiovascular disease, and its results are still pending.

CagriSema vs retatrutide at a glance

Feature Retatrutide CagriSema
What it is One synthetic peptide (LY3437943) Fixed-dose pairing of cagrilintide and semaglutide
Class Triple hormone receptor agonist Amylin analogue plus GLP-1 receptor agonist
Receptors GIP, GLP-1 and glucagon (NEJM 2026) Amylin and GLP-1 (Lancet D&E 2026)
Main research focus Obesity, type 2 diabetes, knee osteoarthritis, sleep apnea Obesity and type 2 diabetes
Best weight result vs placebo −25.0% vs −3.9%, 80 weeks −20.4% vs −3.0%, 68 weeks
Human evidence 33 registered studies; phase 3: TRIUMPH-1, TRIUMPH-2, TRANSCEND-T2D-1 31 registered studies; phase 3: REDEFINE 1, REDEFINE 2, REDEFINE 5, REIMAGINE 3
Approval status Not approved anywhere Not approved; FDA decision expected Q4 2026
WADA S0 (our reading), prohibited at all times Cagrilintide component S0 while unapproved
Route studied Subcutaneous injection, once a week Subcutaneous injection, once a week
Timelines in studies −17.5% at 24 weeks, −24.2% at 48 weeks (phase 2) −15.6% at 32 weeks (phase 2, diabetes)
Outcome trial TRIUMPH-OUTCOMES, ~10,000 people, est. 2029 REDEFINE 3, 7,076 people, est. 2027
Main safety concerns Diarrhea, nausea, dysesthesia, low blood pressure, heart rate rise Nausea and other GI effects, fatigue, stops for side effects

What is retatrutide?

Retatrutide is Eli Lilly’s investigational once-weekly injection. It activates three hormone receptors at once: GIP, GLP-1 and glucagon (TRIUMPH-1). GIP and GLP-1 are gut hormones that curb appetite and help release insulin. Glucagon raises energy use. Its phase 2 trial drew attention with 24.2% weight loss at 48 weeks on the top dose, against 2.1% on placebo [Human RCT, n=338]. Phase 3 then confirmed large losses in people with and without diabetes. Lilly says its clinical data package supports filings for obesity, obstructive sleep apnea and knee osteoarthritis pain (Lilly 8-K).

What is CagriSema?

CagriSema is Novo Nordisk’s fixed-dose combination of cagrilintide, a long-acting amylin analogue, and semaglutide. Semaglutide is the GLP-1 drug already approved as Wegovy for weight management. Amylin is a hormone released with insulin that slows stomach emptying and signals fullness. In REDEFINE 1, weight fell 20.4% against 3.0% on placebo over 68 weeks [Human RCT, n=3,417]. In the Japan–Taiwan REDEFINE 5 trial, it produced 18.4% loss against 11.9% with semaglutide [Human RCT, n=331]. Cagrilintide is not a component of any FDA-approved drug, so the whole product counts as investigational.

Retatrutide vs CagriSema: which comes first?

CagriSema is ahead on every regulatory step. Novo Nordisk’s filing rests on REDEFINE 1 and REDEFINE 2 (Novo, 2025-12-18). The company’s 2026-10-20 announcement still gives Q4 2026 for the US decision and says that “safety and efficacy are not established”. No FDA decision had been announced by 2026-10-31. A decision is not the same as an approval, because the FDA can also ask for more data.

Retatrutide follows about a year behind. Lilly’s 2026-08-05 results filing says the BLA will go to the FDA in the first quarter of 2027. Its third-quarter filing of 2026-10-29 gave no new date. FDA’s PDUFA performance goals aim to act on a new application within 10 months after a 60-day filing period, or within 6 months under priority review. By that arithmetic, a Q1 2027 filing points to a decision around early 2028 under standard review, or late 2027 under priority review. That estimate is ours, not Lilly’s.

In the EU, neither drug was on EMA’s list of new medicines under evaluation with data extracted 2026-09-04. The October 2026 list could not be checked for this update.

How they work differently

  • Retatrutide: one molecule acting on GIP, GLP-1 and glucagon receptors (TRIUMPH-2). The glucagon action is what sets it apart from tirzepatide, which acts on GIP and GLP-1 only.
  • CagriSema: two separate molecules in one product. Cagrilintide acts on amylin receptors and semaglutide on GLP-1 receptors (REIMAGINE 2).
  • Retatrutide: heart rate rose with dose in the phase 2 trial, peaking at 24 weeks and then declining (NEJM 2023) [Human RCT, n=338].
  • CagriSema: the amylin partner added weight loss on top of semaglutide. In a 32-week diabetes trial, the pairing produced 15.6% loss against 5.1% with semaglutide alone (Lancet 2023) [Human RCT, n=92].

Evidence head-to-head

No trial has compared retatrutide with CagriSema directly. The table sets each drug’s best result for each outcome side by side. All figures are cross-trial: the trials differ in length, population and analysis method, so one drug’s number cannot be subtracted from the other’s.

Outcome Retatrutide best evidence CagriSema best evidence
Weight, no diabetes Human RCT (n=2,339): −25.0% vs −3.9%, 80 wk (TRIUMPH-1) Human RCT (n=3,417): −20.4% vs −3.0%, 68 wk (REDEFINE 1)
Weight, type 2 diabetes Human RCT (n=1,152): −18.8% vs −5.1%, 80 wk (TRIUMPH-2) Human RCT (n=1,206): −13.7% vs −3.4%, 68 wk (REDEFINE 2)
Blood sugar (HbA1c) Human RCT (n=537): −1.94 vs −0.81 points, 40 wk (TRANSCEND-T2D-1) Human RCT (n=2,713): −1.91 vs −1.75 points with semaglutide, 68 wk (REIMAGINE 2)
Against semaglutide Human RCT, open-label, topline (n=1,298): weight −19.5% to −20.9% vs −9.4% with Ozempic 2 mg, 80 wk (TRANSCEND-T2D-2) Human RCT (n=331): weight −18.4% vs −11.9% with semaglutide (REDEFINE 5)
Against tirzepatide No head-to-head result published (as of 2026-10-31) Human RCT, open-label (n=809): 23.0% vs 25.5%, non-inferiority missed (REDEFINE 4); type 2 diabetes: −12.4% vs −9.1% with tirzepatide 5 mg, 60 wk, company headline (REIMAGINE 5)
Knee osteoarthritis pain Human RCT subgroup (n=574): pain score −3.6 vs −1.9 (TRIUMPH-1) No trial result found
Sleep apnea Human RCT, 80 wk, efficacy estimand: −36.1 vs −11.1 events/hour on 9 mg without diabetes (n=243, TRIUMPH-1-OSA); −28.4 vs −10.6 on 12 mg with type 2 diabetes (n=448, TRIUMPH-2-OSA) (NEJM 2026) No trial result found
Heart attack, stroke Outcome trial running (NCT06383390) Outcome trial running (NCT05669755)
Indirect comparison Network meta-analysis: −22.1% vs placebo (BMJ Med 2026) Same analysis: −17.3% vs placebo; intervals overlap

A second, larger BMJ network meta-analysis of 262 trials rated CagriSema’s one-year weight loss as moderate-to-high certainty: −14.8% against lifestyle change alone. It graded the retatrutide estimate as very low to low certainty; that estimate fell within a 13.1–14.6% range for emerging drugs [Systematic review, 99,791 participants]. The analysis searched studies only up to November 2025, before the retatrutide phase 3 papers appeared. Retatrutide’s larger numbers have therefore had less independent scrutiny than CagriSema’s.

CagriSema vs tirzepatide vs retatrutide

Tirzepatide is the useful third reference point. It is already approved for weight management as Zepbound (FDA approval 2023-11-08), and it was the comparator in CagriSema’s REDEFINE 4 head-to-head trial. In the phase 3 SURMOUNT-1 trial, tirzepatide 15 mg produced 20.9% weight loss against 3.1% on placebo at 72 weeks [Human RCT, n=2,539]. All rows below are cross-trial except the REDEFINE 4 row.

Outcome Retatrutide CagriSema Tirzepatide
Best placebo-controlled weight loss −25.0%, 80 wk −20.4%, 68 wk −20.9%, 72 wk
REDEFINE 4 (direct) Not tested 23.0%, 84 wk 25.5%, 84 wk
US status Investigational Investigational, decision Q4 2026 Approved (Zepbound)

CagriSema has a second direct comparison with tirzepatide, at lower doses: in adults with type 2 diabetes, REIMAGINE 5 found 12.4% weight loss with CagriSema 1.0 mg/1.0 mg against 9.1% with tirzepatide 5 mg at 60 weeks, on the efficacy estimand [Human RCT, company headline, not yet peer reviewed]. No published trial has compared retatrutide with tirzepatide (as of 2026-10-31). The three-way picture against approved drugs is covered in retatrutide vs tirzepatide vs semaglutide.

Which fits which goal?

  • Largest weight loss: retatrutide has more evidence. It produced the biggest placebo-controlled losses, both in people without diabetes (TRIUMPH-1) and in people with diabetes (TRIUMPH-2) [Human RCT, cross-trial].
  • Knee pain and sleep apnea alongside obesity: only retatrutide has phase 3 results for these conditions [Human RCT].
  • Evidence certainty and an approved component: CagriSema has more evidence. Its semaglutide half is the only obesity drug linked to lower all-cause mortality in the BMJ network meta-analysis, a finding for semaglutide alone that has not been shown for CagriSema [Systematic review]. CagriSema also beat semaglutide alone in REDEFINE 5 [Human RCT, n=331].
  • Regulatory timing: CagriSema’s FDA decision is due first (Novo).

These are statements about evidence, not recommendations. Once either drug is approved, whether it suits a particular person is a decision for a clinician who knows that person’s history.

Can CagriSema and retatrutide be taken together?

No controlled human study of retatrutide with CagriSema or with cagrilintide was found on PubMed or ClinicalTrials.gov (searched 2026-10-31). Both products act on the GLP-1 receptor: retatrutide directly, and CagriSema through its semaglutide half. Combining them would therefore stack two GLP-1 drugs, a pairing no regulator has evaluated.

The one published study of the pairing that was found is in animals. In diet-induced obese male rats, daily co-administration of cagrilintide and retatrutide reduced body weight and food intake more than either drug alone at matched doses. It also improved cholesterol, triglycerides and insulin [Animal, Nature Metabolism 2026]. That study tested cagrilintide without semaglutide, so it is not a test of CagriSema plus retatrutide, and it says nothing about safety in people. What else is known about the cagrilintide pairing is collected in retatrutide and cagrilintide: what is known about the combination.

The FDA has warned companies selling retatrutide labeled “for research purposes”. It calls such products “of unknown quality”. Research peptides promoted online for metabolism sit outside the trial evidence on this page; two of them are compared in MOTS-c vs 5-amino-1MQ: differences, evidence and safety.

Safety and regulatory status

Both drugs share the GLP-1 class profile, led by gastrointestinal side effects, and each has its own signals.

  • Retatrutide, gut effects: in TRIUMPH-2, diarrhea affected 34% on 12 mg against 13% on placebo, and nausea 28% against 8% [Human RCT, n=1,152].
  • Retatrutide, other signals: the same trial found low blood pressure in 6% on 12 mg against under 1% on placebo, and dysesthesia (abnormal skin sensations) was more frequent than on placebo. Treatment stops for adverse events or death reached 12% on 9 mg and 8% on 12 mg, against 5% on placebo. In TRANSCEND-T2D-2, 4.8% (9 mg) and 7.9% (12 mg) stopped for adverse events, against 2.7% on Ozempic 2 mg [Human RCT, topline, n=1,298].
  • CagriSema, gut effects: in REDEFINE 1, 79.6% reported gastrointestinal events against 39.9% on placebo, mostly transient and mild to moderate [Human RCT, n=3,417].
  • CagriSema, other signals: the BMJ network meta-analysis placed it among the drugs with the most stops for side effects. It also found a higher risk of fatigue (risk ratio 3.2) [Systematic review].
  • Long-term unknowns: neither drug has outcome-trial data on heart attacks, strokes or deaths yet. REDEFINE 3 is testing whether CagriSema is non-inferior to placebo on cardiovascular death, heart attack and stroke. TRIUMPH-OUTCOMES is running for retatrutide.

Access outside trials is narrow. Lilly lists a pre-approval expanded-access program for retatrutide (status “Available” on 2026-10-31). It is limited to adults with severe obesity and serious complications who cannot join a trial. The FDA says it has acted against ingredient distributors and outsourcing facilities that sold or repackaged retatrutide. Lilly’s third-quarter filing also lists a call on online platforms, payment companies and regulators to shut down the illegal retatrutide market.

Jurisdiction Retatrutide CagriSema
US (FDA) Unapproved; cannot be compounded; BLA planned Q1 2027 Unapproved; NDA under review, decision expected Q4 2026
EU (EMA) Not on the September 2026 evaluation list Not on the September 2026 evaluation list
UK (MHRA) Unlicensed; seized in a May 2026 raid (MHRA) Not licensed
Sport (WADA) S0, prohibited at all times (our reading) Cagrilintide S0 while unapproved

WADA’s S0 class covers any drug without approval by a government health authority for human therapeutic use, including drugs in clinical development. From 2027-01-01 the class names “peptides” in general, and USADA advises “utmost caution” even for peptides that are not named. Semaglutide and tirzepatide remain permitted and monitored. Anyone who suspects a side effect from retatrutide, CagriSema or any other drug or product can report it to the FDA through MedWatch.

How long do effects take in studies?

  • Retatrutide: in phase 2, weight was down 17.5% at 24 weeks and 24.2% at 48 weeks on the top dose [Human RCT, n=338]. Phase 3 measured its main result at 80 weeks (TRIUMPH-1).
  • CagriSema: in a phase 2 trial in people with diabetes, weight was down 15.6% at 32 weeks [Human RCT, n=92]. In REDEFINE 1 it was down 20.4% at 68 weeks. The 84-week REDEFINE 4 showed 23.0% if taken as intended. In a post hoc analysis of the 2,309 women in REDEFINE 1, the figure was 25.0% at 68 weeks if all adhered to treatment [Human RCT, post hoc subgroup].

What users report

This section summarizes unverified self-reports, mostly from people who bought unregulated products. It is not evidence and cannot show what the real drugs do. People who post about gray-market “reta” commonly describe strong appetite loss and fast early weight loss, often within the first weeks. Recurring complaints are nausea, a racing heart, tingling or sensitive skin, fatigue and feeling cold. Many threads argue about whether a product actually contained retatrutide, and lab-test screenshots are traded as proof either way. Cost is another frequent complaint. Posts about CagriSema itself are rarer, because it has only been given in trials. Most come from trial participants who describe feeling full sooner and lasting nausea. A common debate is whether to wait for CagriSema’s FDA decision or for retatrutide. Another is whether REDEFINE 4’s loss to tirzepatide makes CagriSema the weaker option. Some posters also ask whether the two could be used together.

Frequently asked questions

Is CagriSema better than retatrutide?

Not on weight loss in the trials published so far, though no trial has compared them directly. Retatrutide produced 25.0% loss at 80 weeks in TRIUMPH-1, and CagriSema produced 20.4% at 68 weeks in REDEFINE 1 [both Human RCTs; cross-trial]. A network meta-analysis ranked retatrutide higher, but the confidence intervals overlapped. CagriSema is ahead on regulatory timing.

Which will be approved first, retatrutide or CagriSema?

CagriSema is first in line. Novo Nordisk filed its New Drug Application in December 2025 and said on 2026-10-20 that a US decision is expected in Q4 2026. Lilly plans to file retatrutide in Q1 2027. A decision can still be a rejection or a request for more data, so neither approval is certain.

Is CagriSema better than tirzepatide?

Not at the top doses. In REDEFINE 4, an open-label 84-week trial in 809 adults, CagriSema produced 23.0% weight loss against 25.5% with tirzepatide 15 mg and missed its non-inferiority goal [Human RCT]. In type 2 diabetes, REIMAGINE 5 put it ahead of tirzepatide 5 mg, 12.4% against 9.1% at 60 weeks [Human RCT, company headline]. Tirzepatide is approved as Zepbound; CagriSema is still investigational.

What’s better than retatrutide?

As of 2026-10-31, no drug has beaten retatrutide in a published head-to-head trial. Its only direct comparison so far is against Ozempic 2 mg in type 2 diabetes. There it produced 19.5% to 20.9% weight loss against 9.4% at 80 weeks in TRANSCEND-T2D-2 [Human RCT, open-label, topline, n=1,298]. It has not been tested against tirzepatide or CagriSema.

Can CagriSema and retatrutide be taken together?

No study supports it. No controlled human trial of retatrutide with CagriSema or cagrilintide was found on PubMed or ClinicalTrials.gov (searched 2026-10-31), and both act on the GLP-1 receptor. The one published study found was in obese male rats. There, retatrutide plus cagrilintide cut weight and food intake more than either drug alone, but the study did not include semaglutide and says nothing about safety in people [Animal].

How long does CagriSema take to work?

Trials measured CagriSema’s main results after months, not weeks. In a phase 2 trial in type 2 diabetes, weight was down 15.6% at 32 weeks, against 5.1% with semaglutide alone [Human RCT, n=92]. In REDEFINE 1, the primary result came at 68 weeks: 20.4% against 3.0% on placebo [Human RCT, n=3,417].

References

  1. Jastreboff AM, et al. (2026). Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity (TRIUMPH-1). N Engl J Med. PubMed 42814954
  2. Bellido V, et al. (2026). Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2). Lancet. PubMed 42810372
  3. Bajaj HS, et al. (2026). Retatrutide in type 2 diabetes inadequately controlled with diet and exercise (TRANSCEND-T2D-1). Lancet. PubMed 42250575
  4. Jastreboff AM, et al. (2023). Triple-Hormone-Receptor Agonist Retatrutide for Obesity: A Phase 2 Trial. N Engl J Med. PubMed 37366315
  5. Garvey WT, et al. (2025). Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1). N Engl J Med. PubMed 40544433
  6. Davies MJ, et al. (2025). Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (REDEFINE 2). N Engl J Med. PubMed 40544432
  7. Buse JB, et al. (2026). CagriSema versus semaglutide or cagrilintide in type 2 diabetes (REIMAGINE 2). Lancet Diabetes Endocrinol. PubMed 42251859
  8. Rosenstock J, et al. (2026). Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3). Lancet. PubMed 42251856
  9. Yamauchi T, et al. (2026). Cagrilintide and semaglutide versus semaglutide in Japan and Taiwan (REDEFINE 5). Lancet Diabetes Endocrinol. PubMed 42009015
  10. Frias JP, et al. (2023). Cagrilintide 2.4 mg with semaglutide 2.4 mg in type 2 diabetes: a phase 2 trial. Lancet. PubMed 37364590
  11. Cavender MA, et al. (2026). Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3). Am Heart J. PubMed 42838477
  12. Jastreboff AM, et al. (2022). Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). N Engl J Med. PubMed 35658024
  13. Petersen J, et al. (2026). Cagrilintide and retatrutide combination therapy enhances weight loss and metabolic outcomes in obese male rats. Nat Metab. PubMed 42744908
  14. Chen D, et al. (2026). Comparative efficacy and safety of GLP-1 based drugs for weight loss without diabetes: network meta-analysis. BMJ Med. PubMed 42688617
  15. Nong K, et al. (2026). Comparative effects of drugs for adults with overweight or obesity: systematic review and network meta-analysis. BMJ. PubMed 42419792
  16. Novo Nordisk (2025-12-18). Novo Nordisk files for FDA approval of CagriSema. Company announcement
  17. Novo Nordisk (2026-02-23). CagriSema demonstrated 23% weight loss in REDEFINE 4; the primary endpoint was not achieved. Company announcement
  18. Novo Nordisk (2026-10-20). Novo’s CagriSema was associated with 25% weight loss on average for women in a post hoc analysis of REDEFINE 1. Company announcement
  19. Eli Lilly and Company (2026-08-05). Form 8-K: second-quarter 2026 results. SEC
  20. Eli Lilly and Company (2026-10-29). Form 8-K: third-quarter 2026 results. SEC
  21. Eli Lilly and Company (2026-10-28). 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. News release
  22. US FDA. FDA’s concerns with unapproved GLP-1 drugs used for weight loss (content current as of 2026-10-01). FDA
  23. US FDA. PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 2023 Through 2027. FDA
  24. US FDA. Drugs@FDA: Wegovy (semaglutide), NDA 215256. Drugs@FDA
  25. US FDA. Drugs@FDA: Zepbound (tirzepatide), NDA 217806. Drugs@FDA
  26. European Medicines Agency. Medicines for human use under evaluation. EMA
  27. MHRA (2026-05-29). Two arrested during the MHRA’s largest-ever seizure of unlicensed weight-loss medicines. GOV.UK
  28. World Anti-Doping Agency. The 2026 Prohibited List. WADA
  29. USADA. Athlete Advisory: What’s new on the 2027 WADA Prohibited List? USADA
  30. USADA. Weight loss drugs: what athletes need to know about GLP-1s. USADA
  31. Grunstein RR, Somers VK, Azarbarzin A, et al. (2026). Retatrutide once weekly for treatment of obstructive sleep apnea (TRIUMPH-1-OSA and TRIUMPH-2-OSA). N Engl J Med, published online 2026-10-21. doi:10.1056/NEJMoa2611477
  32. Novo Nordisk (2026-09-21). CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5. Company announcement
  33. ClinicalTrials.gov records: NCT05929066 (TRIUMPH-1), NCT05929079 (TRIUMPH-2), NCT06354660 (TRANSCEND-T2D-1), NCT06260722 (TRANSCEND-T2D-2), NCT06383390 (TRIUMPH-OUTCOMES), NCT07629401 (retatrutide expanded access), NCT05567796 (REDEFINE 1), NCT05394519 (REDEFINE 2), NCT06131437 (REDEFINE 4), NCT05669755 (REDEFINE 3).

Change log

2026-11-02: sleep apnea results updated to the two dedicated phase 3 trials (NEJM, 2026-10-21); CagriSema’s REIMAGINE 5 result against tirzepatide 5 mg added (key points, evidence table, three-way section, FAQ); reviewed by the editorial team.

2026-10-31: all status facts re-checked (Novo’s 2026-10-20 restatement of the Q4 2026 decision, Lilly’s Q2 and Q3 SEC filings, FDA page current as of 2026-10-01, the WADA 2027 List). Added: a CagriSema vs tirzepatide vs retatrutide section with SURMOUNT-1, the rat study of retatrutide plus cagrilintide, REDEFINE 3 design details, REIMAGINE 3, the REDEFINE 1 post hoc analysis in women, ClinicalTrials.gov record counts, and the MedWatch reporting route. Corrected: the WADA retatrutide row is now marked as our reading of S0, the USADA link, the REDEFINE 3 enrollment (7,076), and the TRIUMPH-2 dysesthesia wording (now stated as in the abstract). Removed: the status image dated 2026-10-01. FAQ reworked around reader questions; reviewed by the editorial team.

2026-10-29: Lilly’s 2026-10-28 head-to-head TRANSCEND-T2D-2 result against Ozempic 2 mg added (key points, evidence table, safety, FAQ); Lilly’s 2026-10-29 third-quarter report checked (no new filing date); reviewed by the editorial team.

2026-10-19: links to related entries added; no change to the facts.

2026-10-13: links corrected (a link inside a citation or on a generic word removed); no change to the facts.

2026-10-12: links to related entries added; no change to the facts.

2026-10-06: links to related entries were added on 2026-10-05; no change to the facts.

2026-10-01: first published after review by the editorial team.

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