GLP-1s If You're Not Obese or Overweight: What's Approved, What Isn't

No GLP-1 medicine is FDA-approved for weight loss unless you have obesity, or overweight plus at least one weight-related health problem such as high blood pressure. In the adult trials behind those approvals, that meant a BMI (body mass index) of 30 or more, or 27 to just under 30 with such a problem.^{1, 2, 3, 4} A few approved uses don't depend on weight: type 2 diabetes (for example Mounjaro, Ozempic and Rybelsus) and a liver disease called MASH once it has caused moderate to advanced scarring, but not cirrhosis (Wegovy injection).^{2, 5, 6, 7}

Taking a GLP-1 to lose weight without meeting the weight criteria is off-label, meaning outside the uses FDA approved. For that use, FDA has not determined that the drug is safe and effective, and the UK's medicines regulator says the benefits and risks have not been studied.^{8, 9} If that is your situation, start with your own doctor.

Which of these is you?

• You have type 2 diabetes or a liver disease called MASH: see which approved uses don't depend on weight.
• Your BMI is 25 to 30, or you're not sure where yours falls: see where the BMI lines fall and what to do if you meet them.
• Your BMI dropped because treatment worked: see what your starting BMI means now.
• You want to lose 10 or 20 pounds, or to "microdose": see what that would mean and the risks you would take on.
• Food, weight or your body feels out of control: please talk with a clinician first. Free, confidential help, including at night and on weekends, is listed below.
• None of these fits you: start with the questions to take to your own doctor.

Which GLP-1 uses depend on weight, and which don't

We sorted every approved use on seven current FDA labels by whether weight is part of it.

What "Yes" means. For adults, it means obesity, or overweight with at least one weight-related condition. Wegovy injection and Saxenda are also approved for some children 12 and older with obesity (Saxenda only above 60 kg).^{2, 4}

Diet and exercise are part of most approvals. The labels pair the weight, sleep apnea and liver uses, and Wegovy's heart use, with a reduced-calorie diet and more physical activity. The diabetes medicines pair their blood sugar use with diet and exercise; their heart and kidney uses carry no such clause.^{1, 2, 3, 4, 5, 6, 7}

Same medicines, different names. Zepbound and Mounjaro are both tirzepatide, and Wegovy, Ozempic and Rybelsus are all semaglutide. Foundayo is orforglipron, and Saxenda is liraglutide. Mounjaro, Ozempic and Rybelsus are approved only for type 2 diabetes uses, not for weight loss.^{1, 2, 3, 4, 5, 6, 7}

The uses without a weight rule start with a diagnosis. The type 2 diabetes uses carry no BMI rule, and the Mounjaro, Ozempic and Rybelsus labels say the drugs' effect on blood sugar in trials did not vary with starting BMI.^{5, 6, 7} That is not the same as being tested at every weight, as the trials section below shows.

Wegovy injection is approved for MASH (metabolic dysfunction-associated steatohepatitis, formerly called NASH) in adults whose liver shows moderate to advanced scarring, stage F2 or F3, but not cirrhosis. This is an accelerated approval: FDA granted it based on improvement seen in the liver, and keeping it may depend on a confirmatory trial.²

These uses treat those diseases; they are not a way to get a GLP-1 for weight loss. Prediabetes on its own is not an approved use of any of these medicines.^{1, 2, 3, 4, 5, 6, 7} All of them carry a boxed warning, which is a warning FDA can require to be set in a box on the label for risks that may lead to death or serious injury, along with other serious warnings covered under the risks you would take on.^{1, 2, 3, 4, 5, 6, 7, 10}

Where the BMI lines fall

NIH defines overweight as a BMI of 25 to 30, and obesity as 30 or more.¹¹ If you don't know your BMI, NIH has an adult BMI calculator. For adults, the trials behind the weight-loss approvals set the overweight line a little higher:

• BMI 30 or more: obesity.
• BMI 27 to just under 30: overweight, plus at least one weight-related condition. The trials named high blood pressure, unhealthy cholesterol or other blood fats, obstructive sleep apnea and cardiovascular disease as examples, and NIH's guidance names type 2 diabetes.^{1, 3, 11}
• BMI 25 to just under 27: overweight by NIH's definition, but below the range those trials enrolled. NIH's guidance on prescribing starts at 27, and so do the CVS Caremark and Express Scripts criteria below.^{11, 12, 13}
• BMI under 25: neither overweight nor obesity by NIH's definitions, and well below the adult trials' entry lines, so weight loss is not an approved use.^{1, 2, 3, 4, 11}

Children and teens are judged differently. Their obesity is measured by BMI percentile for age and sex on growth charts, not by these numbers, so their doctor is the one to ask.²

CVS Caremark's Zepbound criteria and Express Scripts' weight-loss GLP-1 policy ask for a BMI of 30 or more, or 27 or more with a weight-related condition, measured before treatment began.^{12, 13} Both companies are pharmacy benefit managers, which employers and health plans hire to run drug coverage, and each plan still decides whether to cover weight-loss drugs at all.^{14, 15} A third, Prime Therapeutics, also accepts a BMI of 25 or more for adults of South Asian, Southeast Asian or East Asian descent.¹⁶ That lower cut-off is Prime's own coverage rule. The trials behind the weight-loss labels enrolled adults from a BMI of 27, and a prescriber decides whether a medicine fits you.^{1, 2, 3, 4}

If you meet these lines, a clinician can tell you whether an approved medicine fits you. Our page on Zepbound prior authorization compares what drug plans ask for and explains how to appeal a denial, and our page on GLP-1 cost covers prices without insurance.

On Medicare? Under federal law, drugs used for weight loss are not part of the basic drug coverage that Part D plans provide, though a plan with enhanced coverage is allowed to add them as an extra (supplemental) benefit. Check your plan's drug list.^{17, 18, 19}

Separately, Medicare's temporary GLP-1 Bridge, running from July 1, 2026, through December 31, 2027, covers some GLP-1 medicines for weight management for a $50 copay. To use it, you need Part D coverage and prior authorization (approval before it pays), and you must meet its BMI-based criteria, which below a BMI of 35 also require a listed health condition. It excludes anyone already getting a GLP-1 through Part D, and people with type 2 diabetes, moderate to severe sleep apnea, or MASH with stage F2 or F3 scarring but not cirrhosis, whose Part D plan may cover a GLP-1 for those uses instead.²⁰ Our page on UnitedHealthcare coverage has a full section on how the Bridge works.

If your BMI is lower because treatment worked

The weight-loss labels approve these medicines both to reduce excess weight and to keep it off long term.^{1, 2, 3, 4} So for someone whose BMI has fallen on treatment, the question is whether to continue. That is a decision to make with the prescriber who knows your history.

Some coverage rules look back to where you started. Express Scripts judges BMI "at baseline", which it defines as before any GLP-1 medicine, and CVS Caremark tells its reviewers to consider the BMI from the start of any weight-loss drug.^{12, 13} Medicare's Bridge requires its criteria to have been met when GLP-1 treatment began; CMS's example is someone who started at a BMI of 37 and is at 34 now.²⁰ None of this applies to someone who did not meet the criteria at the start.

If you change prescribers or plans, bring a dated record of your weight and BMI from before you started. Our page on Zepbound prior authorization shows which plans use your starting BMI. If you have taken compounded tirzepatide, which a pharmacy makes for one patient's prescription, our page on switching to Zepbound asks whether a plan will count that time.

Weight tends to return after stopping.²¹ In one Zepbound trial, adults without type 2 diabetes who met the weight criteria took the highest dose they could tolerate (10 or 15 mg a week) for 36 weeks; on average, those who were then switched to a placebo ended the next 52 weeks 14.0% heavier than when they switched, while those who stayed on Zepbound lost a further 5.5%. These results are for Zepbound, not for compounded tirzepatide.¹ Our page on tirzepatide weight loss over time covers results like these.

What the trials did not test

Each approval rests on trials that chose people by weight or by diagnosis:

• Weight loss (Zepbound, Wegovy, Foundayo, Saxenda): in each label, a large adult trial enrolled people within the BMI lines above.^{1, 2, 3, 4}
• Heart risk (Wegovy): adults 45 or older with a BMI of 27 or more and established cardiovascular disease (a prior heart attack or stroke, or peripheral artery disease), and without diabetes.²
• Sleep apnea (Zepbound): adults with obesity, meaning a BMI of 30 or more.¹
• MASH (Wegovy): people were chosen by liver biopsy, not BMI. Of 800 in the main analysis, 53 (7%) had a BMI under 25, and the label says information on people with MASH and a BMI under 25 is limited.²
• Type 2 diabetes (Mounjaro, Ozempic, Rybelsus): these uses carry no BMI rule. The labels don't say whether their blood-sugar trials (average BMIs ran from 31 to 35) or the Ozempic and Rybelsus heart and kidney trials had a BMI entry rule. Mounjaro's heart-risk trial, SURPASS-CVOT, enrolled only adults with a BMI of 25 or more.^{5, 6, 7}

The UK's medicines regulator, the MHRA, describes the gap plainly. The benefits and risks of using these medicines for weight loss by people who do not have obesity, or who are not overweight with weight-related conditions, "have not been studied," it wrote in 2024.⁹ In July 2026 it added that the GLP-1 medicines approved in the UK "have only been shown to be safe and effective for people with a Body Mass Index (BMI) of 27 or more."²² UK approvals differ from US ones: in 2024 the MHRA listed Mounjaro among the medicines licensed in the UK for weight management.⁹

Losing 10 or 20 pounds, or "microdosing"

No GLP-1 is approved to help someone who doesn't meet the weight criteria lose a few pounds, so a prescription for that would be off-label. FDA says that once it approves a drug, doctors generally may prescribe it for an unapproved use when they judge it medically appropriate, for example when no approved drug treats a condition or approved treatments have not helped, but FDA has not determined that the drug is safe and effective for that use.⁸ That rule is about FDA-approved drugs. Compounded GLP-1s are not FDA-approved at all, and FDA says they should be used only when an approved drug cannot meet a patient's medical needs.²³

The drug-plan criteria above would not cover it for anyone below their BMI lines.^{12, 13, 16} FDA also counts a drug "given in a different dose" as off-label.⁸ That includes microdosing, meaning smaller-than-labeled doses. Zepbound's label, for example, says its starting dose is only for beginning treatment and is not approved as a maintenance dose.¹

A 2026 report for nurse practitioners describes microdosing as an unsupervised practice. It says people try it partly to avoid stomach side effects and to lose weight for appearance, and it flags dosing errors and the risks of altering pens, using compounded vials and sharing medicine.²⁴ The Zepbound, Mounjaro, Wegovy, Ozempic and Saxenda labels all say never to share a pen, even with a new needle, because sharing can spread serious infections.^{1, 2, 4, 5, 6}

NIH is direct about cosmetic use. Experts worry that in some cases the side effects of these medicines may outweigh the benefits, it says, so "never take a weight management medication only to improve the way you look."¹¹ The UK regulator has also warned clinicians about misuse for "aesthetic weight loss."⁹

PlexusDx, which publishes this page, offers a lower-dose plan called Microdose GLP-1, made with compounded semaglutide or tirzepatide. Dosing below the doses on the FDA labels is off-label, so this plan is too.⁸ Like any compounded GLP-1, its medicines are not FDA-approved, FDA does not review them for safety, effectiveness or quality before they are sold, and they were not the products tested in the trials behind the approvals.²³ Every warning under the risks you would take on applies to it.

A smaller dose does not make a GLP-1 approved for someone outside the label criteria. If that describes you, the place to start is your own doctor, not a lower-dose plan from an online seller, PlexusDx's Microdose GLP-1 among them.

If food or your body feels out of control

If eating, weight or the way your body looks has started to feel out of control, please talk with a doctor or therapist before you look for any weight-loss medicine. Getting help with that comes first.

Free, confidential help. The National Alliance for Eating Disorders runs a helpline staffed by licensed therapists who specialize in eating disorders. Call (866) 662-1235, Monday to Friday, 9 a.m. to 7 p.m. Eastern, or email referrals@allianceforeatingdisorders.com.²⁵

That helpline is not a 24-hour crisis line. For free support at any hour, call or text 988, the Suicide and Crisis Lifeline, or text ALLIANCE to 741-741. In a medical emergency, call 911.²⁵

A 2026 consensus from a panel of 45 people, including experts in diabetes, obesity and eating disorders and people with lived experience, recommends screening for current or past eating disorders before anyone starts a GLP-1, and watching for symptoms during treatment. Its concern is that these medicines' appetite-suppressing and weight-loss effects could worsen an eating disorder or bring one on.²⁶

The panel says these medicines should generally be avoided during an active eating disorder, especially anorexia nervosa, atypical anorexia nervosa, or bulimia nervosa with strict dieting or major weight loss, and it urges caution after a past eating disorder.²⁶ Atypical anorexia means having the symptoms of anorexia while your weight stays in or above the normal range, so a normal BMI does not rule out an eating disorder.²⁷

Some people hope a GLP-1 will help with binge eating. The panel calls the early results preliminary and asks for trials, and no GLP-1 is approved to treat any eating disorder.^{1, 2, 3, 4, 5, 6, 7, 26} If you already take one and eating starts to feel out of control, tell your prescriber.

The risks you would take on

The UK regulator says the benefits and risks of using these medicines for weight loss by people who don't meet the weight criteria have not been studied, so no one can say how much weight you would lose or how safe that would be for you.⁹ Every label warning still applies, and a smaller dose is still off-label.^{1, 8}

Go over these points with a prescriber before you start, stop or change a medicine. A few things below need action right away; for those, don't wait for an appointment. This is not every risk: each FDA-approved medicine comes with a Medication Guide that lists more. Compounded products have no FDA-approved Medication Guide, so go through these warnings with the prescriber and pharmacist and ask what else applies to that product.^{1, 23}

Some warnings apply even if you don't have diabetes or much weight to lose.

Low blood sugar. The Zepbound, Foundayo and Wegovy labels report low blood sugar in adults without type 2 diabetes, and Saxenda's label reports it in teens without diabetes. It is more likely with insulin or a sulfonylurea (a type of diabetes pill).^{1, 2, 3, 4}

Signs of low blood sugar include dizziness, sweating, confusion, shakiness, a fast heartbeat and hunger. The UK regulator, which has reminded clinicians that this can happen in people without diabetes who use some of these medicines for weight, says patients should know these signs and seek medical advice urgently if they occur.^{1, 9}

Stomach side effects and dehydration. Nausea, diarrhea, vomiting and constipation are the most common side effects and can be severe; tell your prescriber about stomach problems that are severe or won't go away. Vomiting or diarrhea can lead to dehydration and kidney injury, in some cases needing dialysis.¹

The UK regulator has had reports of severe dehydration after these stomach side effects, including in people who may not have met the prescribing criteria.⁹ If nausea, vomiting or diarrhea won't stop, drink fluids and tell your prescriber right away.¹

Muscle. The Zepbound, Wegovy and Foundayo labels say these drugs cause more fat loss than lean loss, which means some muscle and other lean tissue is lost too.^{1, 2, 3} A 2024 review reports that lean tissue made up 40% to 60% of the weight lost in some studies and about 15% or less in others.²⁸

The review adds that lean mass includes organs, bone and fluids, not just muscle, and that in imaging studies, muscle loss looked in line with age, health and the weight lost. It says older age may still affect who is a suitable candidate, because of the risk of muscle loss (sarcopenia).²⁸

Nutrition. A 2025 advisory from four lifestyle, nutrition and obesity medicine groups lists nutrient deficiencies from eating less, and loss of muscle and bone, among the challenges of treatment.²¹ Our page on vitamins and supplements explains what changes when you eat less on tirzepatide.

Other warnings call for fast action if they happen.

Pancreatitis. The labels warn of inflammation of the pancreas, including severe cases that have been fatal. For severe stomach pain that won't go away, with or without nausea or vomiting and sometimes spreading to your back, stop the medicine and call your prescriber right away.^{1, 2}

Serious allergic reactions. Anaphylaxis and angioedema (swelling under the skin) have been reported. For signs of a serious allergic reaction, such as a swollen face, lips, tongue or throat, trouble breathing or swallowing, a severe rash or itching, fainting or dizziness, or a racing heartbeat, stop the medicine and get medical help right away.¹

Gallbladder. Gallbladder problems are more common on these drugs than on placebo: in Wegovy's adult weight trials, gallstones were reported in 1.6% of people on the injection and 0.7% on placebo. Call your prescriber right away about upper stomach pain, fever, yellow skin or eyes, or clay-colored stools.^{1, 2}

And some decide whether you should start at all, or need a talk with the prescriber first.

Thyroid tumors (the boxed warning). Tirzepatide, semaglutide and liraglutide caused thyroid C-cell tumors in rats or mice.^{1, 2, 4} Orforglipron, Foundayo's drug, has no action on the GLP-1 receptor of rats and mice, so animal studies could not test whether it causes these tumors. It does act on the human form of that receptor, and Foundayo carries a boxed warning for the same risk, with the same rule about who must not take it.³

It is not known whether any of these drugs causes thyroid C-cell tumors in people, including a thyroid cancer called medullary thyroid carcinoma (MTC). Tell your prescriber about a neck lump or swelling, hoarseness, trouble swallowing or shortness of breath.^{1, 2, 3, 4}

Who must not take them. No one with a personal or family history of MTC, or with an endocrine condition called multiple endocrine neoplasia syndrome type 2 (MEN 2), should take them. Neither should anyone who has had a serious allergic reaction to the drug or anything in it. They are not recommended for people with severe gastroparesis, which is very slow stomach emptying.^{1, 2, 3, 4, 5, 6, 7}

Eye disease with type 2 diabetes. In people with type 2 diabetes, a fast improvement in blood sugar can temporarily worsen diabetic eye disease (retinopathy). In a 2-year Ozempic trial, eye complications occurred in 3.0% of people on Ozempic and 1.8% on placebo, with a bigger rise in people who already had retinopathy. If you have diabetic eye disease, tell your prescriber before you start, and report any change in vision.^{1, 6}

Other medicines. The Zepbound, Wegovy, Foundayo and Saxenda labels advise against taking them with any other GLP-1 medicine, and that includes compounded semaglutide or tirzepatide. Because these drugs slow stomach emptying, they can change how pills taken by mouth are absorbed; Zepbound's label, for example, names warfarin as a drug to monitor.^{1, 2, 3, 4, 5, 6, 7}

Surgery and sedation. That slower emptying is also why every label here warns of rare reports of people breathing food or liquid into their lungs while under anesthesia or deep sedation. Before any procedure, tell everyone treating you, dentists included, that you take a GLP-1.^{1, 2, 3, 4, 5, 6, 7}

Pregnancy. All seven labels warn of possible harm to an unborn baby, based on animal studies for Mounjaro, Ozempic and Rybelsus. If you become pregnant while taking Zepbound, Foundayo or Saxenda, or Wegovy for weight or heart protection, stop it and tell your prescriber. NIH says never to take a weight-management medicine during pregnancy or while planning one.^{1, 2, 3, 4, 5, 6, 7, 11}

The Mounjaro, Ozempic and Rybelsus labels say they should be used in pregnancy only if the possible benefit is worth the possible risk, so anyone taking one for diabetes who is pregnant or planning to be should talk with the prescriber before stopping. Ozempic and Rybelsus, and Wegovy for weight or heart use, should be stopped at least 2 months before a planned pregnancy.^{2, 5, 6, 7}

Birth control and breastfeeding. Birth-control pills may not work as well with Zepbound, Mounjaro or Foundayo. Their labels advise women on the pill to switch to a non-pill method, or add a barrier method such as condoms, for the first 4 weeks and for 4 weeks after every dose increase (30 days for Foundayo). Breastfeeding is not recommended with Wegovy tablets, Rybelsus or Ozempic tablets, or Foundayo.^{1, 2, 3, 5, 7}

Too much, or a side effect to report. If someone takes too much, call the prescriber or Poison Help (1-800-222-1222), or go to an emergency room right away. To report a side effect to FDA, call 1-800-FDA-1088.¹

Newer definitions of obesity that look beyond BMI

Some medical groups argue that BMI alone is a poor measure of one person's health. Here is where four of them stand, in the order they published:

• European Association for the Study of Obesity (July 2024): diagnose obesity by belly fat and health problems, not BMI alone. Its framework counts people with a BMI of 25 to 30 who carry extra fat around the abdomen and have related medical, functional or psychological problems as having obesity, and its experts agreed that obesity medicines should be considered for them when the waist-to-height ratio is above 0.5. EASO notes that today's trial-based criteria rule these medicines out at such BMIs, and it calls for future trials to rely less on BMI cut-offs. It is a European proposal, not a US rule: the US weight-loss approvals rest on trials that enrolled adults with a BMI of 30 or more, or 27 to under 30 with a weight-related condition, and the drug-plan criteria above still use BMI lines.^{1, 2, 3, 4, 12, 13, 16, 29}
• Lancet Diabetes & Endocrinology Commission (January 2025): use BMI only to screen. Its 58 experts, whose recommendations 76 organizations endorsed, advise confirming excess fat with a waist measurement or a direct body-fat measurement, using cut-offs suited to age, gender and ethnicity. BMI can underestimate body fat in older people, in people who have lost muscle or bone and in some groups such as Asian populations, its report notes, and can overdiagnose obesity in very muscular people.^{30, 31} It separates "clinical obesity" (excess fat already harming how organs or the body work, which should get timely treatment) from "preclinical obesity" (organs still working normally), for which it recommends counseling, monitoring and, when appropriate, steps to lower risk.³⁰
• Obesity Medicine Association (January 27, 2025): keep BMI as a screen, with waist ratios and clinical judgment. OMA warned that splitting obesity into "preclinical" and "clinical" risks recasting it as a risk factor rather than a disease, and could cost people insurance coverage for treatment, including medications.³²
• American Association of Clinical Endocrinology (2025): look past BMI to complications. Its updated obesity algorithm calls for "complication-centric care," aiming at health goals other than "a singular focus on body mass index."³³

As of October 3, 2026, none of these positions has changed the FDA labels or the coverage criteria on this page, which still rest on BMI.^{1, 12, 13, 16, 20} A waist measurement can tell your doctor more about your health risks; it does not make a GLP-1 approved for you.

Online shortcuts regulators warn about

A 2026 report describes people buying illicit "research-grade" peptides from online sources and from unregulated providers, which it says include medical spas.²⁴ Regulators warn against these routes:

• "Research" products. FDA has sent warnings to companies that illegally sold semaglutide, tirzepatide and similar drugs labeled "for research purposes" or "not for human consumption," yet sold them to consumers with dosing instructions. It urges people not to buy them: their quality is unknown, and they may be harmful.²³
• Sellers that skip screening. FDA's warning signs include a company that "does not require a screening and prescription by a licensed doctor" and one that offers "deep discounts or prices that seem too good to be true."²³
• Unregulated websites. The UK regulator tells people who are not eligible for a prescription not to buy weight-loss medicines from unregulated websites or social media sellers.²²

Compounded semaglutide and tirzepatide are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they are sold.^{23, 34} FDA's guidance says a lower price alone does not justify making what is essentially a copy of an approved drug.³⁵ The trials on this page tested the brand-name medicines, not compounded products.^{1, 2}

FDA says many side effects reported with compounded semaglutide and tirzepatide look like those of the approved drugs, and that reports are likely incomplete because federal law does not require state-licensed pharmacies that are not outsourcing facilities to send them. FDA has also received reports of side effects, some needing hospital care, that may be related to dosing errors with compounded semaglutide injections. So go through the warnings above with a prescriber for any GLP-1 product.²³ Our page on choosing a compounded tirzepatide provider explains what the law allows and the checks to run on any provider.

Questions to take to your own doctor

If you don't fit the approved uses, the best next step is your own doctor, before you turn to an online seller. PlexusDx sells compounded GLP-1 treatment online, so this applies to our programs too. NIH's first step for people struggling with their weight is a healthy eating plan and regular physical activity, and it says weight-management medicines are meant for people with health problems related to their weight.¹¹

FDA suggests questions like these about any off-label use, and NIH says you should feel comfortable asking whether a medicine is approved for treating overweight and obesity.^{8, 11}

• Is this use approved for someone like me, or would it be off-label?
• Are there approved treatments for my situation, and is this likely to work better than they would?
• What studies support this use, and what are the possible benefits and risks for me?
• Will my insurance cover it?
• Are there clinical trials I could join?

Two more questions come from this page. "Should we check for an eating disorder before we talk about medicines?"²⁶ And "Would a waist or body-fat measurement change how you judge my health risks?"^{30, 32}

PlexusDx and the label criteria

PlexusDx publishes this page, so here is how its programs measure up against what you have just read. They are for adults 18 and older. Clinicians from Lone Star Virtual Health, the company that provides PlexusDx's prescribing clinicians, make the medical decisions, not PlexusDx: they review each person's medical history and decide whether to prescribe, and PlexusDx does not guarantee that anyone will qualify.

PlexusDx does not sell or ship brand-name medications. If you would prefer a brand-name, FDA-approved medication, your provider may write a prescription you can fill at the pharmacy of your choice.

Lone Star's physicians use the same rules for all three plans (semaglutide, tirzepatide and Microdose GLP-1): a BMI of at least 25 for people with no GLP-1 use in the two months before they apply, or at least 22 for people continuing one. Both cutoffs sit below the lines described above for Wegovy and Zepbound, so a person with a BMI of 25 to 26.9, or 27 to 29.9 without a weight-related condition, could start treatment through PlexusDx only off-label; the intake says the physician will go over any off-label use before treatment starts. Its screening asks everyone about eating disorders, past or present, including anorexia or bulimia, along with thyroid cancer and pancreatitis, and asks women about pregnancy; it does not ask about diabetic retinopathy, planned sedation, or allergy to B12 or glycine. Our provider guide lists every intake question. Before any prescription, go through the warnings above with the prescriber, including who must not take these medicines. If you do not fit the approved uses described on this page, the advice above applies here too: start with your own doctor.

The medicines in PlexusDx's programs are compounded, so they are not FDA-approved, FDA does not review them for safety, effectiveness or quality before they are sold, and they were not the products tested in the trials on this page.^{23, 34} They come as weekly injections or daily orally disintegrating tablets (ODT). Each of PlexusDx's injections contains an added ingredient, vitamin B12 or glycine, and none is offered without one; Lone Star says the add-in has to match the patient's clinical needs. The tablets' ingredient lists have not been made public. FDA-approved semaglutide tablets are Rybelsus (also labeled as Ozempic tablets) and Wegovy tablets; FDA has not approved any compounded semaglutide tablet. No tirzepatide tablet is FDA-approved.

If a prescriber suggests a compounded medicine, ask why it fits your needs better than an FDA-approved one. The same question applies to PlexusDx's programs, Microdose GLP-1 included. Lone Star Virtual Health says the answer must be specific to the patient: its physicians record it, share it with the patient together with the fact that the medicine lacks FDA approval, and may lean on added B12, B6 or glycine only where the patient's clinical needs justify it. It does not offer a typical answer.

If you fit the approved uses described on this page and are weighing PlexusDx, the questions for your own doctor are worth asking the Lone Star clinicians too. Microdose GLP-1, PlexusDx's lower-dose plan, is off-label, as explained under microdosing.

Sources

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8. Understanding Unapproved Use of Approved Drugs "Off Label" (content current as of 02/05/2018), U.S. Food and Drug Administration, accessed October 3, 2026.
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10. 21 CFR § 201.57: Specific requirements on content and format of labeling for human prescription drug and biological products (paragraph (c)(1), boxed warning), Legal Information Institute, Cornell Law School, accessed October 3, 2026.
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How we made this page

The table of approved uses comes from reading the seven current FDA labels on DailyMed side by side, and the same reading pulled out who each trial enrolled. That is how the gap below a BMI of 27, the BMI floor of 25 in Mounjaro's heart trial and the MASH trial's 7% under 25 came to light. AI tools did that reading. They also read FDA's pages on off-label use, compounding and unapproved GLP-1 products, a federal labeling rule, NIH's pages on weight-management medicines and BMI, two statements from the UK regulator, the Medicare law and rules and CMS's Bridge page, drug-coverage documents from three pharmacy benefit managers, the National Alliance for Eating Disorders' help pages, and the journal papers and medical-society statements on defining obesity, eating disorders, muscle loss and microdosing.

All were opened on October 3, 2026. The AI drafted the text from those sources, and the statements about PlexusDx from PlexusDx's own records and published terms. Each quote in our evidence file from a label, a plan's criteria, a regulator or a journal, such as a trial's entry rule or an insurer's BMI line, was matched by script to the copy of that source saved when it was read. The draft then went through two rounds of AI review. Each round had six reviewers who worked alone, each on one job: medical safety, whether every figure and quote matches its source, regulatory exposure, whether a first-time visitor can follow the page, whether an outside reviewer would trust it and find it original, and whether the statements about PlexusDx hold up. They looked hardest for any sentence that could read as a way to get a GLP-1 below the label lines, trial entry rules that did not match their labels, helpline and crisis-line details that had changed, and wording that breaks FDA's rules on compounded drugs or Google's spam policies. An AI editor then fixed what they found, such as an insurer statement and a missing warning about diabetic eye disease. Then an AI reviewer with no access to the drafts read the page, and a later AI check confirmed the small edits made after that reading.

Software checks like these cannot replace a doctor's or a lawyer's review. We did not use or test any company's program for this page, and statements about PlexusDx are its own as of October 19, 2026. This page replaces two older PlexusDx posts on this question, which did not meet our editorial policy; none of their text or claims was kept.

Jay Hastings reviewed and approved this version on October 19, 2026. Dr. Asad K. Niazi, MD, MPH, reviewed the medical content on October 17, 2026. He is co-founder and CEO of Lone Star Virtual Health, the company that provides PlexusDx's prescribing clinicians, so he has a business relationship with PlexusDx. PlexusDx sells compounded GLP-1 treatment, so we have a financial interest in this topic. Our editorial policy sets out how we handle that interest and how to report an error.