FDA Approves Innovative Weight Management Drug: Zepbound

On November 8, the U.S. Food and Drug Administration (FDA) announced the approval of a new weight management drug, Zepbound (tirzepatide), developed by Eli Lilly and Company. This approval is noteworthy because Zepbound is the first obesity treatment to work by targeting two specific hormone receptors.

Zepbound is an injectable prescription medication that, when used alongside a healthy diet and regular exercise, aids in long-term weight management. It's designed for individuals who are overweight or obese.

How Does Zepbound Work?

Zepbound's unique approach to weight management involves activating two hormones: GIP and GLP-1. These hormones are key in controlling blood sugar levels and appetite, making Zepbound an innovative treatment in the field of chronic weight management.

GIP (Glucose-Dependent Insulinotropic Polypeptide)

• Role in the Body: GIP is a hormone that's released when we eat. Its main job is to help manage how our body uses sugar from the food we eat.
• How it Promotes Weight Loss: When Zepbound activates GIP receptors, it helps our body use sugar more effectively. This means less sugar is stored as fat. Also, by improving sugar handling, it may reduce cravings for sugary foods, indirectly aiding in weight management.

GLP-1 (Glucagon-Like Peptide-1)

• Role in the Body: GLP-1 is another hormone released after eating. It has a crucial role in keeping blood sugar levels balanced and signals to our brain that we are full.
• How it Promotes Weight Loss: By stimulating GLP-1 receptors, Zepbound helps you feel fuller for longer periods, reducing the urge to eat excessively. This hormone also slows down stomach emptying, so you feel satisfied with smaller portions. Additionally, it helps in maintaining steady blood sugar levels, which can reduce cravings and prevent overeating.

Zepbound's Approval: Based on Extensive Clinical Trials

The FDA's approval of Zepbound stems from the results of two significant phase 3 trials, SURMOUNT-1 and SURMOUNT-2, which began in 2019.

SURMOUNT-1 Trial

This large-scale study involved 2,539 adults who were either obese or overweight with additional weight-related health issues, but not diabetes. The participants added Zepbound to their diet and exercise plans. Over a 72-week period, those using Zepbound showed remarkable weight loss compared to those who received a placebo (a non-active treatment).

Weight Loss Results

• Participants on the highest dose of Zepbound (15 mg weekly) lost an average of 48 pounds.
• Those on the lowest dose (5 mg weekly) lost an average of 34 pounds.

Noteworthy Outcomes

Impressively, about one-third of the participants on the 15 mg dose of Zepbound lost over 58 pounds, which was more than 25% of their body weight. In comparison, only 1.5% of those taking a placebo achieved similar weight loss.

These findings underscored Zepbound's effectiveness in significant weight reduction, leading to its approval for weight management therapy.

Who Can Use Zepbound for Weight Loss?

Zepbound is designed for certain adults who meet specific criteria for weight management therapy.

A key principle in healthy eating is balance, rather than categorizing foods as "good" or "bad" or resorting to meal skipping. It's about making informed food choices and understanding the value of moderation and variety in your diet.

A healthy diet is diverse and balanced, incorporating various food groups in appropriate proportions. Here's a breakdown of what it typically includes:

• Adults with a Body Mass Index (BMI) of 30 kg/m² or more, which is classified as obesity.
• Adults with a BMI of 27 kg/m² or above (considered overweight) who also have weight-related health issues like high cholesterol, high blood pressure, type 2 diabetes, obstructive sleep apnea, or cardiovascular diseases.

Dosage and Administration

Zepbound is administered as a subcutaneous injection (just beneath the skin), and here's how it typically works:

• Starting Dosage: 2.5 mg once a week.
• Dosage Increase: After four weeks, 5 mg per week.
• Maintenance Dosage: The long-term dose can vary, ranging from 5 mg to 15 mg once a week, depending on how well you respond to the medication.

Administration

• Frequency: once a week
• Injection Sites: stomach, thigh, or upper arm.
• Important Tip: Change the injection site each time. This helps in reducing discomfort and potential skin issues.

Missing a Dose

If you forget to take your weekly dose of Zepbound, inject it as soon as you remember, and then adjust your schedule so that this new day becomes your regular injection day moving forward. However, if more than four days have elapsed since your missed dose, it's better to skip that dose altogether and resume your injections on your usual scheduled day. This helps maintain a consistent weekly routine, which is crucial for the effectiveness of Zepbound.

Side Effects

It's important to be aware of the potential side effects when starting a new medication like Zepbound. Here's what you might expect:

Common Side Effects

• Nausea
• Constipation or Diarrhea
• Vomiting
• Abdominal Pain
• Indigestion
• Fatigue
• Reactions at the Injection Site

Serious Side Effects

• Severe Allergic Reactions: Watch out for symptoms like hives, difficulty breathing, and swelling of your lips, tongue, throat, or face.
• Low Blood Sugar (Hypoglycemia): Symptoms can include hunger, increased heartbeat, shakiness, anxiety, sweating, tingling, dizziness, blurred vision, weakness, and confusion.
• Severe Stomach Problems: Look out for persistent stomach pain, nausea, vomiting, and diarrhea.
• Kidney Issues: Symptoms might include nausea, vomiting, difficulty urinating, muscle cramps, swelling in ankles or feet, or breathing difficulties.
• Gallbladder Problems: These can present as upper stomach pain, fever, jaundice (yellowing of skin or eyes), or clay-colored stools.
• Pancreatitis (Inflammation of the Pancreas): Be alert for nausea, vomiting, and stomach pain.
• Mental Health Changes: This includes depression or suicidal thoughts and behaviors.

If any of these serious side effects occur, contact your doctor immediately and stop taking the medication. Remember, managing side effects effectively is an essential part of any treatment plan.

Zepbound During Pregnancy

Currently, there's not enough research to confirm its safety during pregnancy. In fact, studies in animals have suggested potential risks to the unborn baby. Additionally, weight loss during pregnancy is generally not recommended due to potential risks to the baby. If you become pregnant while using Zepbound, contact your healthcare provider immediately for advice.

Speak with Your Doctor

Before starting Zepbound, having a conversation with your doctor is vital. They can help assess its suitability for your specific health needs, considering its proven effectiveness in clinical trials. Remember, managing weight is an important aspect of overall health, and your doctor can guide you on the best strategies for achieving and maintaining a healthy weight.