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Retatrutide's 104-Week Data Shows 85-Pound Average Loss — FDA Filing Expected This Year, Access Concerns Mount

The 104-Week Number Nobody's Leading With
A smaller subset of patients with severe obesity continued on retatrutide for 104 weeks — two full years. According to NBC News, that group lost an average of 85 pounds.
The prior 80-week trial showed 28.3% average body weight loss, up to 70.3 pounds, at the 12mg dose. The new 104-week data reveals the drug keeps working. Patients didn't plateau and fall off. They kept losing.
How This Stacks Up — Apples to Apples
For context, here's what the other approved drugs deliver at their highest doses, according to NBC News:
- Wegovy (semaglutide): ~15% body weight lost over 68 weeks
- Zepbound (tirzepatide): ~21% body weight lost over 72 weeks
- Retatrutide at 80 weeks: ~28.3% body weight lost
- Retatrutide at 104 weeks (severe obesity subset): ~85 pounds average
NBC News notes these are NOT head-to-head trials. Different patient populations, different timeframes. The weight loss trajectory stands out nonetheless.
Why This Drug Is Different
Dr. Susan Spratt, endocrinologist and senior medical director at Duke Health, explained the mechanism to both WRAL and NBC News. Retatrutide is a triple agonist — it targets GLP-1, GIP, AND glucagon simultaneously. Wegovy hits one hormone. Zepbound hits two. Retatrutide hits three.
"Something about that combination is causing really dramatic weight loss for people who have obesity," Spratt told WRAL.
Spratt called these results "the largest weight loss I've ever seen in any medication trial." She had no involvement in the trial.
Dr. Shauna Levy, medical director of the Tulane Weight Loss Center, told NBC News the current GLP-1 drugs often aren't enough for patients with severe obesity — BMI of 35 or above. Bariatric surgery fills that gap today. Retatrutide appears poised to challenge that.
According to WRAL, 65% of participants taking the 12mg dose dropped below a BMI of 30 — moving out of the clinically obese category entirely.
FDA Approval: Not Yet
The drug is NOT approved. Lilly told NBC News it expects to file for FDA approval "as early as this year" — meaning 2026. Filing is not approval. Approval is not availability. Availability is not affordability.
Real steps remain between this trial data and a doctor writing a prescription.
The Side Effect Picture
Nausea, constipation, and diarrhea were among the side effects reported, according to NBC News. Dr. Spratt also flagged something worth watching: rapid weight loss without proper nutrition and exercise can strip muscle and bone mass alongside fat. This isn't unique to retatrutide, but it's a legitimate concern at weight-loss levels this dramatic.
Spratt, per WRAL: medication works best alongside healthy food and exercise — not instead of it.
The Access Problem
Spratt told WRAL directly: "I'm sure the drug is going to be priced expensively. It works really well. There's no reason for a company to cut the price."
Wegovy currently runs roughly $1,300/month without insurance. Zepbound is in similar territory. There is no reason to expect Lilly will price a drug that outperforms both at a discount.
Medicare coverage of weight loss drugs remains restricted. Medicaid coverage varies by state. Employer insurance coverage is inconsistent. The Americans who carry the highest obesity burden — lower-income, rural, uninsured — are the least likely to access a drug priced for the commercially insured.
Spratt said she is "very concerned about the cost of these life-saving medications." She called them "life-altering" and argued access shouldn't be limited to the wealthy.
The Trial Has One Big Gap
Lilly has NOT published the full Phase 3 results in a peer-reviewed medical journal, according to NBC News. The data comes from a company press release. That's standard for Phase 3 announcements, but the full dataset — safety signals, subgroup outcomes, dropout rates — hasn't been independently scrutinized yet.
What This Means
Retatrutide at two years delivers weight loss numbers that rival gastric bypass surgery. The 104-week data, the triple-hormone mechanism, and the 65% of patients who moved out of obesity entirely represent genuine clinical progress.
A press release is not a peer-reviewed study. FDA filing is not approval. A drug that only wealthy people can afford doesn't end an epidemic. It changes who has access to treatment.