Zepbound (tirzepatide) has emerged as a significant player in the realm of weight loss and weight management. Approved by the FDA, it offers a promising solution for individuals seeking to lose weight, maintain weight loss, and address related health issues like obstructive sleep apnea. This article delves into the intricacies of Zepbound, exploring its mechanism of action, clinical trial results, usage guidelines, potential side effects, and cost considerations.
What is Zepbound?
Zepbound (tirzepatide) is an FDA-approved medicine used for weight loss and weight management to help you lose weight and keep weight off, and it is also used for obstructive sleep apnea (OSA) with obesity. It shares the same active ingredient as Mounjaro, a medication primarily used for type 2 diabetes. Both are manufactured by Eli Lilly and Company. However, Zepbound is specifically indicated for chronic weight management in adults.
How Zepbound Works
Zepbound works by reducing your appetite and making you feel full more quickly and for a longer period of time, so you eat less and lose weight. Zepbound works like two natural hormones in our bodies, called GIP and GLP-1, which help control appetite, blood sugar levels, and digestion.
Tirzepatide, the active ingredient, functions as a dual-acting GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. These are incretin hormones naturally produced by the body. When Zepbound binds to GIP and GLP-1 receptors, it slows the rate food passes through your body, making you feel full longer, and the pancreas releases more insulin, lowering the amount of sugar your liver makes.
Clinical Trial Results: SURMOUNT Program
The effectiveness of Zepbound has been demonstrated in several clinical trials, most notably the SURMOUNT program. These studies evaluated Zepbound's impact on weight loss and related health markers.
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SURMOUNT-1
The Phase 3 SURMONT-1 study compared weight loss with tirzepatide (Zepbound) to a placebo (inactive) treatment over a 72-week period. Patients taking tirzepatide started at a dose of 2.5 mg once-weekly and then increased the dose by 2.5 mg at four-week intervals to reach their final dose. Final maintenance doses were set at 5 mg, 10 mg, or 15 mg. The study co-endpoints were the percentage change in weight (with the 10 mg and/or 15 mg dose) from the start of the study (baseline) and the percentage of participants with a weight loss of 5% or more at 72 weeks, compared to placebo.
The average starting weight for study participants in SURMOUNT-1 was 105 kg (231 lb). At the highest dose (15 mg), people using Zepbound lost an average of 21.8 kg (48 lb) or 21% of their body weight, while at the lowest dose (5 mg), people lost an average of 15.5 kg (34 lb) or 15% of their body weight, compared to 3.2 kg (7 lb), or 3%, on placebo.
SURMOUNT-2
The Phase 3 SURMONT-2 study compared weight loss with tirzepatide (Zepbound) to a placebo (inactive) treatment over a 72-week period. Patients were randomized to receive Zepbound 10 mg, Zepbound 15 mg, or placebo once weekly. Weight loss with both Zepbound doses as compared to placebo was statistically significant. The average starting weight for adult participants in SURMOUNT-2 was 101 kg (222 lb). People using Zepbound lost on average 50.3 lbs (22.8 kg).
SURMOUNT-OSA
When Zepbound was used for obstructive sleep apnea 42% of adults had no sleep apnea or mild, non-symptomatic OSA after 1 year of treatment, compared to 16% using placebo (SURMOUNT-OSA phase 3 clinical trials).
SURMOUNT-5
The SURMOUNT-5 clinical trial results were published in the New England Medical Journal article Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. For the primary endpoint, patients on Zepbound had a 47% greater relative weight loss compared to Wegoy (an average weight reduction of 20.2% with Zepbound compared to 13.7% with Wegovy). Secondary endpoints demonstrated at least a 15% weight loss in 64.6% of those in the Zepbound group compared to 40.1% on Wegovy. In addition, an average waist circumference reduction of 7.2 in (18.4 cm) was seen in the Zepbound group, compared to an average reduction of 5.1 in (13 cm) in the Wegovy group, a significant effect (P<0.001).
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Key Takeaways from Clinical Trials
- Significant Weight Loss: Zepbound consistently demonstrated significant weight loss compared to placebo across various dosages.
- Dose-Dependent Response: Higher doses of Zepbound generally led to greater weight loss.
- Maintenance of Weight Loss: Patients were able to maintain the weight reduction for the full 72-week study period.
- Improved Health Markers: Beyond weight loss, Zepbound has shown promise in improving conditions like obstructive sleep apnea.
Dosage and Administration
Zepbound is usually given once a week and can be given with or without meals at any time of the day. Zepbound is injected under the skin (subcutaneously) using a pre-filled pen or a single-dose vial with a syringe. Caregivers or patients should be trained on proper injection techniques. You should follow the directions on your prescription label carefully and ask your pharmacist or doctor to explain any part you do not understand. It is important to use this medicine exactly as directed.
Zepbound (tirzepatide) single-use pens deliver 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 and 15 mg doses. The recommended starting dosage is 2.5 mg subcutaneously once weekly, increasing to 5 mg once weekly after 4 weeks. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.
Take the missed dose as soon as you remember it within 4 days after the missed dose. However, if more than 4 days have passed, skip the missed dose and continue your regular dosing schedule.
Who is Zepbound For?
Zepbound may be the right choice for you if: You have obesity. You have excess weight and other health problems because of it. Some examples of health problems related to excess weight are hypertension (high blood pressure), dyslipidemia (high levels of fat, including cholesterol and triglycerides, in the blood), type 2 diabetes, apnea (when breathing pauses repeatedly during sleep), and heart disease.
Your health care provider will measure your weight and height and calculate your body mass index (BMI) by dividing your weight (in kilograms) by your height (in meters) squared. If your BMI is 27 or more, you have excess weight. If your BMI is 30 or more, you have obesity. Your doctor will also examine you and review your medical history to decide if Zepbound is right for you.
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Important Considerations Before Starting Zepbound
Before starting Zepbound, it's crucial to have an open discussion with your healthcare provider about your medical history, current medications, and any potential risks. Here are some key considerations:
- Pregnancy and Breastfeeding: Tell your healthcare provider if you are pregnant, you become pregnant, or plan to become pregnant while using this medicine. Tell your doctor if you become pregnant while taking this medicine. There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. It is not known whether Zepbound passes into your breast milk.
- Birth Control: Zepbound can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.
- Medications: Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- Diabetes Medications: Taking Zepbound with other medicines to treat diabetes, like insulin or sulfonylureas, may increase your risk of hypoglycemia.
- Other Oral Medicines: Zepbound slows gastric emptying and so may change the absorption of other oral medicines that you take.
- Thyroid Cancer Risk: In studies with rats, tirzepatide and medicines that work in the same way caused thyroid tumors, including thyroid cancer. Do not use if you or your family have a history of a type of thyroid cancer called MTC (medullary thyroid carcinoma) or MEN 2 (multiple endocrine neoplasia syndrome).
Potential Side Effects
Like all medications, Zepbound can cause side effects. It's important to be aware of these potential effects and discuss any concerns with your doctor.
Common Side Effects
The most common side effects of Zepbound include:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Stomach (abdominal) pain
- Indigestion
- Injection site reactions (skin sensitivity where the injection goes in your skin)
- Feeling tired
- Allergic reactions
- Belching
- Hair loss
- Heartburn
Serious Side Effects
In addition to common side effects, Zepbound may cause serious side effects:
- Risk of thyroid cancer. Inform your doctor if you notice a lump or swelling in your neck, have raspy or low voice (hoarseness), trouble swallowing, or shortness of breath.
- Gallbladder Problems: Zepbound can cause gallbladder problems such as gallstones or gallbladder inflammation. Tell your doctor if you have nausea, notice yellowing of your skin or eyes, or experience severe stomach pain.
- Vision Changes: If you have type 2 diabetes, tell your health care providers if you notice any change in your vision while you are on Zepbound.
- Mood Changes: Be aware of changes in your mood and mental state. Inform your health care providers if you have unusually negative feelings or thoughts that worry you.
- Dehydration: Make sure to drink lots of fluids to stay hydrated throughout the day, especially if you have nausea or diarrhea, or you vomit.
Managing Side Effects
- Digestive system: To help with nausea, diarrhea, constipation, indigestion, or heartburn, try:Adding fruits and vegetables to your dietDividing your daily meals in multiple smaller portionsStaying away from greasy or heavy meals that are difficult to digest
- Dehydration: Not having enough water in your body (dehydration) can cause, or worsen, kidney problems, especially if you also take other medications that increase water loss such as diuretics (water pills). Some signs of dehydration include dry mouth, excessive thirst, and dizziness.To help avoid dehydration:Make sure to drink lots of fluids to stay hydrated throughout the day, especially if you have nausea or diarrhea, or you vomit. Stay away from drinking large amounts of coffee and alcohol while you are on Zepbound.
Cost and Availability
Lilly has priced Zepbound at about $1,060 for a monthâs supply, and while itâs less than Wegovy, which is priced at around $1,300, both drugs may be too expensive for many people who are eligible. Insurance companies often refuse to cover weight loss medications. Medicare, by law, does not cover them.
A Zepbound coupon or Zepbound savings card may be available that you could be eligible for. With the Zepbound coupon or Zepbound savings card, people with insurance may be eligible to pay as low as $25 for a one-month or three-month prescription. Those who are commercially insured but without coverage for Zepbound may be eligible for savings for a one-month prescription of Zepbound. Zepbound vials cost has been reduced making them more cost effective for self-pay patients.
Zepbound vs. Other Weight Loss Medications
Ozempic, Mounjaro, Wegovy and Zepbound are injectable medications that can all lead to long-term weight loss, but only Wegovy and Zepbound are approved by the FDA for this use. Ozempic and Wegovy both contain semaglutide, a GLP-1 (glucagon-like peptide-1) receptor agonist. Mounjaro and Zepbound both contain tirzepatide, a dual-acting GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist.
While all these medications can be effective for weight loss, they have different FDA-approved uses, dosages, and potential side effects. Research is ongoing to determine whether patients lose more weight with Zepbound or Wegovy.
Real Patient Experiences
The provided text includes numerous testimonials from individuals who have experienced positive outcomes with weight management programs that include medications like Zepbound. These patients report:
- Significant weight loss
- Improved confidence and self-esteem
- Better fitting clothes
- Increased energy levels
- Improved sleep
- Positive changes in their relationships
The LifeMD Weight Management Program
The LifeMD Weight Management Program includes access to medications like Wegovy® and Zepbound®, if appropriate. This program combines groundbreaking GLP-1 medications, lab testing, and the knowledge of leading clinicians to create a highly effective approach to weight loss. Licensed medical professionals provide comprehensive care, including your initial visit, coaching provided by your weight loss team and ongoing medical check-ins from the comfort of your home.
Program Components
- Expert clinician consultations
- Personalized prescriptions
- Dedicated coaching
- Essential lab work (if you haven't completed the required tests within the last 12 months)
- Access to GLP-1 medications like Wegovy® or Zepbound®