Retatrutide Promises Big Weight Loss, But Safety Remains a Question

Retatrutide Is a New GLP-1 Hit. But Is It Legal?

Retatrutide Is a New GLP-1 Hit. But Is It Legal?
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You’ve heard of the popular glucagon-like peptide-1 (GLP-1) receptor agonist drug semaglutide (Ozempic, Wegovy) and GLP-1/GIP drug tirzepatide (Mounjaro, Zepbound). Now there’s a new kid on the weight loss block — or at least one that’s hanging around a dark weight loss alley.

Retatrutide is being hailed as a game changer for obesity by social media health influencers and those on weight loss forums, thanks to a handful of early clinical trials showing it could help users shed pounds faster than other drugs currently on the market. While it’s possible to purchase online without a prescription, retatrutide isn’t an FDA-approved medication. It hasn’t been thoroughly tested for safety or efficacy, which means this weight loss drug could put your health at risk.

What Is Retatrutide?

Retatrutide is an experimental weight loss drug. It’s still being studied for safety and efficacy and has yet to be approved by the U.S. Food and Drug Administration (FDA) for any nonexperimental use in humans.

Similar to injectable weight loss medications like semaglutide and tirzepatide, retatrutide targets receptors in the body that suppress appetite and lower blood sugar. But unlike its predecessors, retatrutide is a triple-receptor agonist, targeting receptors for three hormones: glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and glucagon.

 Semaglutide, on the other hand, targets only GLP-1, while tirzepatide targets GLP-1 and GIP.

The fact that retatrutide targets three different receptors may make it more effective than the current crop of weight loss therapies.

“Think of the glucagon receptor as a third tier,” says Sue DeCotiis, MD, a triple-board certified weight loss specialist and a clinical instructor at the NYU Grossman School of Medicine in New York City. “Working on that third receptor may provide added effects for appetite inhibition and insulin sensitivity.” In other words, it may help people lose more weight faster.

In a phase 2 trial of 338 adults with obesity, those who took the highest dose of retatrutide (12 milligrams) lost an average of 24 percent of their body weight over 48 weeks.

By comparison, in phase 3 clinical trials, semaglutide yielded an average weight loss of 16 percent over 68 weeks, and tirzepatide yielded an average weight loss of 20 percent over 72 weeks.

Phase 2 trials also reveal that retatrutide may help reduce A1C levels significantly, while also decreasing liver fat levels and improving kidney function in people with type 2 diabetes.

But until researchers publish retatrutide’s phase 3 results, these benefits are considered preliminary. This stage will massively expand the scope of testing in order to more fully understand retatrutide’s benefits, risks, and side effects. This data is necessary before the FDA can evaluate whether a drug is ready for the general public.

A phase 3 clinical trial for retatrutide is currently underway and expected to wrap up in May 2026.

 “After the trial is complete, the FDA usually takes 6 to 10 months to review the study once the results are submitted,” says Michael Snyder, MD, the medical director of bariatric surgery at HCA HealthONE Rose in Denver, and an in-house obesity specialist at FuturHealth. “Potentially, the drug could be approved as early as 2027 if no issues or concerns arise.”

Is Retatrutide Legal?

While retatrutide still has a ways to go in research before getting the green light from the FDA, online sources are already selling the drug. Does that mean it’s okay to buy it? The answer is complicated.

It is illegal to sell retatrutide for human use for nonresearch purposes. Retatrutide (and any other drug that has yet to receive FDA approval) cannot be sold or compounded in pharmacies.

 “Retatrutide cannot be legally prescribed or dispensed outside of authorized clinical trials,” says Dr. Snyder. “Since there is no FDA-approved retatrutide product, pharmacies and compounders cannot legally compound it.” So far, the FDA has sent warning letters to nearly a dozen online storefronts that are doing so.

A review of online sources suggests that suppliers aren’t transparent about this rule. Some highlight retatrutide’s rapid weight loss benefits while dancing around the fact that the medication hasn’t been FDA approved, referring to it as an “investigational drug” or one that’s “still undergoing clinical research.” Those that do mention the lack of FDA approval tend to do so in tiny print at the bottom of a product page. Some suggest vaguely that some kind of medical evaluation will take place or that buyers must sign a release.

Other storefronts avoid health claims while stating that their retatrutide is intended for research purposes. “They get around [the FDA’s restrictions] by saying the product is for lab use, or not for human or veterinary use,” says Dr. DeCotiis. But there’s usually nothing stopping the average person from buying these products, either. “It’s a little bit shady,” she says.

When suppliers operate in legal gray areas like this, it seems unclear if the act of purchasing retatrutide is illegal. Retatrutide isn’t a banned drug, and “the substance itself isn’t necessarily illegal,” says Tenille Davis, PharmD, the chief advocacy officer for the Alliance for Pharmacy Compounding.

 But experts have no confidence that retatrutide purchased on the gray or black market is the substance it’s supposed to be.

Is Retatrutide Safe?

There isn’t enough information to determine whether retatrutide is safe. The medication hasn’t completed the clinical drug trial process yet and thus isn’t approved by the FDA. Those unknown risks could be even greater when purchasing “retatrutide” from an illicit source, because it hasn’t been regulated or evaluated by health authorities, says DeCotiis.

Preliminary research suggests that retatrutide seems to have a fairly similar side effect profile to semaglutide and tirzepatide, including nausea, diarrhea, constipation, and vomiting. A handful of trial participants also experienced more serious adverse effects, such as increased heart rate, elevated liver enzymes, and kidney problems.

 Experts are also worried about the possible effects of retatrutide’s very rapid weight loss. “There’s a concern that there may be a greater likelihood of bone fractures,” says Snyder.

These risks may not be deal breakers for most people, and it’s very likely that retatrutide will be approved by the FDA within the next few years, says DeCotiis. But it’s important to have a clear understanding of the drug’s risks before it can be safely prescribed. “We need to better understand how the dosing and dose intervals affect all of the above risks and results,” says Snyder.

Experts also warn that buying compounded retatrutide from an online pharmacy that isn’t supposed to be selling it in the first place could be dangerous. “If you’re buying a drug through illegitimate channels, you may run into quality control issues,” says DeCotiis.

“There’s no guarantee that what [the retailer says is in it] is actually in it,” says Davis. “It could be contaminated.” You could also end up receiving a product with an incorrect dosage, which could pose additional health risks.

What’s more, since you’re getting it without a prescription, “there’s no medical oversight if you develop complications like severe GI effects, pancreatitis, gallbladder issues, dehydration, or dangerous drug interactions,” says Snyder. “You assume medical, quality, and legal risks without any of the safeguards that are built into regulated care.”

Weight loss medications should be taken under the supervision of a healthcare provider, which isn’t available when you purchase retatrutide online without a prescription. “You need to be monitored,” says DeCotiis.

Retatrutide’s purported results may be tempting, but experts agree that you should not purchase or use the drug now. If you’re interested in trying a weight loss medication, make an appointment with your doctor to discuss FDA-approved options like semaglutide or tirzepatide.

"I strongly advise patients to stick with FDA-approved, properly regulated prescription medications prescribed through licensed medical providers,” says Snyder. “That’s the only way to ensure you’re receiving a real drug at the right dose under appropriate medical supervision.”

The Takeaway

  • Retatrutide is an experimental triple-receptor agonist drug that has shown promising weight loss results in preliminary clinical trials.
  • The drug is not yet approved by the FDA and is still undergoing a phase 3 clinical trial, which is expected to conclude in 2026.
  • Despite the lack of approval, some online storefronts are purportedly selling retatrutide online, sometimes claiming that the substance is “for research purposes only.”
  • Experts strongly caution against buying any form of retatrutide, as the entire market is unregulated, and even the legitimate compound has not yet been studied sufficiently to know that it is safe.
EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Resources
  1. FDA’s Concerns With Unapproved GLP-1 Drugs Used for Weight Loss. U.S. Food and Drug Administration. September 25, 2025.
  2. Katsi V et al. Retatrutide—A Game Changer in Obesity Pharmacotherapy. Biomolecules. May 30,2025.
  3. Jastreboff A et al. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. New England Journal of Medicine. August 10, 2023.
  4. Wadden T et al. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. April 13, 2021.
  5. Kumbhani D et al. Tirzepatide Once Weekly for the Treatment of Obesity - SURMOUNT-1. American College of Cardiology. November 13, 2024.
  6. Decision Support Tool: Features to Consider in Determining if a Clinical Trial is Phase II or Phase III. National Institutes of Health.
  7. A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3). ClinicalTrials.gov. July 23, 2025.
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  10. Compounding and the FDA: Questions and Answers. U.S. Food and Drug Administration. September 16, 2025.

Kristina D. Carter, PharmD

Medical Reviewer

Kristina D. Carter, PharmD, is a clinical pharmacist and freelance health writer who currently works in a managed care setting, performing quality audits on utilization management case reviews for the pharmacy team. She has over 20 years of experience and has worked in several pharmacy practice settings, including at a community pharmacy as well as in ambulatory care, senior care, and pharmacy operations.

She received her doctor of pharmacy degree from Xavier University of Louisiana College of Pharmacy and her master's of business administration and health administration from Georgia State University Robinson College of Business. She is an American Council on Exercise–certified health coach, group fitness instructor, senior fitness specialist, and weight management specialist. She is also a registered pharmacist, licensed in Georgia, Indiana, and Tennessee.

Dr. Carter enjoys exploring new restaurants with family and friends, walking along city trails, and watching action movies and college sports.

Marygrace Taylor

Marygrace Taylor

Author

Marygrace Taylor is an award-winning freelance health and wellness writer with more than 15 years of experience covering topics including women’s health, nutrition, chronic conditions, and preventive medicine. Her work has appeared in top national outlets like Prevention, Parade, Women’s Health, and O, The Oprah Magazine.

She's also the coauthor of three books: Eat Clean, Stay Lean: The Diet, Prevention Mediterranean Table, and Allergy-Friendly Food for Families. She lives in Philadelphia.