Eli Lilly phase 3 Eloralintide trial is enrolling for "Plateau Busting" research

declan

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I was looking into the current phase 3 study for Eli Lilly's Eloralintide and I found that the trial is actually currently open and looking for volunteers. I thought I'd pass it along.

This is actually a "plateau busting" study, they're looking for people on tirz or sema who stalled. I think that may describe many of us who hit a wall and are exploring an amylin receptor agonist to break the plateau.

Elly Lilly will provide you free Eloralintide (or a placebo) to see whether it helps you break through your plateau. It's not clear to me whether they provide tirz or a stipend for it. Maybe someone else can clarify.

Some information/requirements:
  • Study ID: NCT07392190
  • Duration: 80 weeks (approximately 1.5 years)
  • Commitment: 22 clinic visits
  • BMI: > 30 OR > 27 with at least one health issue (e.g., hypertension, sleep apnea).
  • Medication Stability: On a stable, prescribed dose of a weekly GLP-1/GIP (Tirzepatide or Semaglutide) for the last 90 days.
  • Weight Stability: Your weight must have remained within a 5% range (stalled) for the last 90 days.
  • Documented History: Must have at least one self-reported unsuccessful attempt to lose weight through diet/exercise.
Before you call a site, make sure none of these disqualifiers apply to you. If they do, you may need to wait 90 days before applying.
  • Dose changes: if you increased or decreased your glp-1 in the last 90 days wait until you have 3 months of stability.
  • Active weight loss: if you gained or lost more than 5% of your total body weight you won't qualify. They're looking for people who are truly stalled.
  • Gray market peptide use: the trial protocol requires you to be on a "stable background incretin therapy" (their words).
    • To a clinical researcher, "Stable" means they can see an official medical record or pharmacy receipt showing you received exactly 10mg or 15mg of FDA-approved Tirzepatide (Zepbound/Mounjaro) for the last 90 days.
  • No major surgeries or adverse health events in the last 90 days.
This study is extremely important to all of us. I ask that you only consider if you really plan to commit (e.g., not discontinue because you suspect you're on the placebo which is apparently a problem plaguing glp-1 studies).

You can apply by calling a study center near you to see if you qualify.

https://clinicaltrials.gov/study/NCT07392190

Good luck and thank you if you apply and help move the science forward.
 
I am extremely pleased to see this being done. The current ( non grey ) GLP's are great and reta will be once it is finally approved, but for people with more severe obesity , they are still not really good enough. I hope their definition of stalled is not an issue, 5% change over 90 days is equivalent to 20% change over a year, which is very definitely not stalled, so hopefully in practice they are a bit stricter than 5% in 90 days so the results are more meaningful.
Eloralintide plus reta is probably current grey state of the art in terms of weight loss, or will be once eloralintide is more available. Results from tirz plus eloralintide should be a good indication of how effective it is as an add on. Will be a while before there are results but there will not be studies of reta or tirz plus cagri due to different ownership, so should be interesting.
 
declan said:
To a clinical researcher, "Stable" means they can see an official medical record or pharmacy receipt showing you received exactly 10mg or 15mg of FDA-approved Tirzepatide (Zepbound/Mounjaro) for the last 90 days.
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Yeah, I'm going to guess this is a problem for most of us in this space. I do have a prescription for 12mg of tirzepitide from my PCP, but I haven't used it since my first (and only) compounding purchase in June of last year. My doc just asks what I'm taking and then adjusts the standing prescription based on my report. Maybe they would take my crypto purchase history as proof I've been on reta since last August. Oh, I guess, I'm not stalled yet either. It sounds like I wouldn't be a good candidate. Which is ok, because I'd hate to be in that placebo group.
 
Novo did Cargi, this is Lilly (as you stated). Seems promising for the plateau busting market.

Cagrilintide: activates amylin + calcitonin

Eloralintide: designed to be more selective for amylin receptors with less calcitonin receptor activity
 
RetCurious said:
How long till it hits gray? 😆
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Uther has already announced they’ll have it soon. The rumor floating around is that a kit will be around $300, but no word on how many mg are in those kits. The discussion remains about analytical testing capabilities as there’s no indication there’s a standard to test against yet. But they must be close or Uther wouldn’t be close to production either.
 
This is very interesting! They aren't recruting in Australia yet but I still signed up on Lilly's website to see if I'm eligible. Technically, I still have a script for Mounjaro, even though I'm using Gray tirz. I wonder if they will exclude people on reta?
 
How is this different from cagrilintide?
 
EAM9112 said:
How is this different from cagrilintide?
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Pretty different. Biochemically, cagrilintide isnt a specific amylin 1/3 agonist. It also affects calcitonin receptors. Eloralintide is specific to amylin 1/3 only. More interestingly, cagri shows modest weight loss of some ~10% while eloralintide clocks in at ~20% after about a year of use.

So quite a significant difference on weight loss between the two.
 
TooGood76 said:
In an interview the CEO of Lilly said that he thinks it'll be bigger than reta because they are seeing 20% body weight loss with almost no GI side effects.
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Yeah and imagine what would happen if they stack it with reta or even tirz 🤯. Lilly is way ahead of novo.
 
Devilseye said:
Yeah and imagine what would happen if they stack it with reta or even tirz 🤯. Lilly is way ahead of novo.
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Right I think they are testing stacking it with tirz. Probably Reta+ results with less side effects. He seemed very confident that one of the tow would be a blockbuster drug.
 
TooGood76 said:
Right I think they are testing stacking it with tirz. Probably Reta+ results with less side effects. He seemed very confident that one of the tow would be a blockbuster drug.
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I am currently in the screening process for this trial. They are stacking eloralintide or the placebo with either semaglutide or tirzepatide. If you qualify you get 6 months of whichever one you are already on for free and either eloralintide or the placebo.
 
I actually got the link to complete the initial questionnaire off an Eli Lilly instagram ad. Basic health info, medical conditions, and questions about current dosage of zepbound and weight loss for the last few months. I then completed a phone interview and I gave consent for them to contact my doctor to access my medical records. I've been asked to come in twice for labs and a physical. I have not had to provide proof of meds yet. I have a prescription from my Dr so they can see that in my records, but I haven't filled it since September. Also, according to the shotsy app, I've lost more than 5% of my body weight in the last 3 months. Not sure what my weight was on my medical records, so this may not be a problem. Next visit in 2 weeks, is the final screening to see if I get into the study.
 
frosty18 said:
I am currently in the screening process for this trial. They are stacking eloralintide or the placebo with either semaglutide or tirzepatide. If you qualify you get 6 months of whichever one you are already on for free and either eloralintide or the placebo.
Click to expand...

Thats a super interesting study!! I mean there is synergy between cagri and sema so ill be extra interested in the synergy of elora with tirz given BOTH are more efficacious than cagri/sema! I hope it lives up to my expectations which are in the 30% range over a year. Well see what the 6 month range gives you but i expect that itll hopefully be way above even reta.
 
Anything plateau busting would be amazing. I might have to look into the study. 6 months free tirz and a new drug would be kinda nice. Even if you just get placebo, not a bad deal!
 
thebonus said:
Anything plateau busting would be amazing. I might have to look into the study. 6 months free tirz and a new drug would be kinda nice. Even if you just get placebo, not a bad deal!
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And you get paid for all the visits. I haven't officially qualified yet, but they told me it would total about $4000 if I got to all 21 appointments.
 
Dos-Dox said:
Uther has already announced they’ll have it soon. The rumor floating around is that a kit will be around $300, but no word on how many mg are in those kits. The discussion remains about analytical testing capabilities as there’s no indication there’s a standard to test against yet. But they must be close or Uther wouldn’t be close to production either.
Click to expand...
I absolutely need some of that. Theres a person on my life over 400 pounds and the tirz/reta barely touches them, just not steong enough no matter how much he takes. If it was available id certainly research and pick up a kit of it
 
Calm Logic said:
It is supposedly at Uther right now, ready to order. No test results yet though. And a whopping $3.50 a mg (10-mg kit for $350).
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The doses in the study were 1 to 9mg, so at high doses $32 a week. Expensive by current grey GLP price standards where tirz is 0.25 c US per mg, but pretty similar to what I was paying for 1mg/w of genuine ozempic at a bit less than AU $40/w. A bit out of my price range right now but the other GLP's have dropped quite a lot in price over the year I have been on here, round about half what they cost then.
 
Dos-Dox said:
Uther has already announced they’ll have it soon. The rumor floating around is that a kit will be around $300, but no word on how many mg are in those kits. The discussion remains about analytical testing capabilities as there’s no indication there’s a standard to test against yet. But they must be close or Uther wouldn’t be close to production either.
Click to expand...
said 10mg according to one of their admins
 
Calm Logic said:
Do you know when Uther is shipping it? Or when the test results may be available? I am not planning on getting a kit anytime soon, but I am curious about the test results.
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They are waiting for the coa according to the admin
 
lessthanhalf said:
The doses in the study were 1 to 9mg, so at high doses $32 a week. Expensive by current grey GLP price standards where tirz is 0.25 c US per mg, but pretty similar to what I was paying for 1mg/w of genuine ozempic at a bit less than AU $40/w. A bit out of my price range right now but the other GLP's have dropped quite a lot in price over the year I have been on here, round about half what they cost then.
Click to expand...
Sure after its novelty wears off it will become much more affordable!!
 
lessthanhalf said:
The doses in the study were 1 to 9mg, so at high doses $32 a week. Expensive by current grey GLP price standards where tirz is 0.25 c US per mg, but pretty similar to what I was paying for 1mg/w of genuine ozempic at a bit less than AU $40/w. A bit out of my price range right now but the other GLP's have dropped quite a lot in price over the year I have been on here, round about half what they cost then.
Click to expand...
What I am worried about: Orfo has not gone down in price at all really. So maybe this in another orfo regarding pricing if only a few vendors will carry it.
 
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