Great news, a fast track designation has been given for Mounjaro FDA approval for weight loss in adults. What does this mean? Let’s dig into the details.
While the initial Mounjaro FDA approval is for Type 2 Diabetes, expect an approval in 2023 for obesity in adults. For thousands who are currently using Tirezepatide for weight loss off-label, this comes as promising news as many hope that insurance will cover this as the Mounjaro coupon ends in 2023.
Pending Mounjaro FDA Approval for Obesity / Weight Loss
We have had many discussions here on Keto Dirty, including my on-going personal Mounjaro weight loss story. So when logging on this morning and seeing a headline that Tirezepatide could be officially granted FDA approval, needless to say I was elated.
Over the course of using Mounjaro, not only have I experienced weight loss – but have had a new understanding of obesity as a disease and not just me being lazy or un-motivated.
While typically these headlines make me say “this could be a game changer” – after seeing so many have success, including myself, I can say “this is a game changer.” Sure, it’s not for every single person – but isn’t that the case for every diet? Personally, I do believe we have seen a break-thru for unlocking obesity.
What is FDA Fast Track Designation?
The Mounjaro FDA approval for weight loss was granted a fast track designation, but what does that even mean? A FDA fast track designation is granted to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need.
- Learn what is currently approved for obesity.
Mounjaro Clinical Trials
There are currently Mounjaro clinical trials being done for adults with obesity. This is standard practice for when wanting to get FDA approval.
From reading in different communities, the obesity Mounjaro clinical trials are under way which is a key step in the approval process. Read the entire NIH study.
Weight Loss
Clinical trials for Type 2 Diabetes are available for review and if you are interesting in losing weight with Mounjaro, this you might find fascinating.
Here are quotes from the clinical trials, again this was for Type 2, not obesity.
- “I think that when I had the loss of appetite, I realized that I could actually control…my sugar better based on what I was actually eating.” (F, 56 y)
- “I’m not craving food and sweets like I did before especially. Not craving food is great.” (M, 65 y)
- “My cravings weren’t so strong and I could, I could overcome that…A lot of binge eating before the shot. After the shot, I was able to control it better.” (M, 71 y)
Energy
While losing weight is a huge part of why many of us start a health journey, those NSV (non-scale victories) are also a benefit. A NSV that I can attest to is energy. Here is what participants in the first Mounjaro clinical trial had to say in regards to energy.
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My body just felt good. There were times when I really felt like I could paint a whole house. So it gave me the energy that I needed to stay independent in my life…There was hope. My biggest thing was hope that I could get my sugar down and I could live with this.” (F, 63 y)
- “It did a lot for my energy…The more weight I lost, the better I felt.” (M, 52 y)
- “I didn’t feel sluggish at work. I think I had more energy. I worked a little bit faster.” (F, 56 y)
- “I felt like doing more things. And that’s great because, you know, you feel like living… I had more energy to go outside and work in the garden and do my exercise, and actually do more stuff around the house.” (M, 71 y)
Learn more about Mounjaro side effects.
Mounjaro Approval Timeline
While the exact timeline for Mounjaro FDA approval for weight loss is dependent on multiple factors, all signs are pointing to a Spring / Summer 2023 approval. The process is tedious and has significant requirements, rightfully so.
As we learn more in regards to timeline and news on the Mounjaro FDA approval for obesity, we will keep you in the know. Stay tuned!
Sheila kay
Tuesday 21st of February 2023
I am looking to lose weight is like to try the shots
Donna
Monday 20th of February 2023
I was doing so well on Mounjaro and then had to suddenly discontinue it because my insurance wouldn't pay for it since it was not approved for weight loss. My doctor put me on another approved medication and I feel absolutely terrible and haven't lost anything. I actually feel like it makes me retain fluid. I am so ready to resume Mounjaro. I hope it is approved soon.
Lynn Buckhalter Bland
Wednesday 15th of February 2023
I started Mounjaro in 11/22. I have completed 3 months thus far and lost 22 lbs. Approx 1-3 pounds a month. I’m currently waiting on the 4th month RX doing 7.5 mg for 2nd month to maintain. I’m at BMI 26. I have ^cholesterol, ^blood pressure, and had fatty liver (NA). My BP has stabilized and I’m waiting on labs for other results. Look better and feel better! Just wish the supply would level out.
Melissa Flinner
Friday 9th of December 2022
I've been on the program Calibrate and have been taking Mounjaro for weight loss and was receiving at the cost of $25, well now Eli Lily has taken that savings card away from the people that have obesity. I now have to wait and see if the program is going to be able to keep me on this medication or if I end up on something else. I really want to be able to stay on this because I have had noticeable weight loss and feel better as well. I don't understand why if these medications help in the process of losing weight and keeping a person from contracting type 2 diabetes, heart issues, and other health issues that they wouldn't be approved for weight loss as well and be covered under your health insurance. Whether you are diagnosed with diabetes or obesity it shouldn't matter, especially if the medication is preventing or helping with a disease.
Isabel
Monday 21st of November 2022
Hi I’m trying to get the mounjaro injection but it says my coupon won’t go thru. Is there something going in. It says coupon is good till December 2023. I am a diabetic my A1c is high. I was hoping to get help with this. But I can’t afford to pay $400.