Latest / GLP-1 Newspaper: Daily Ozempic, Zepbound & Weight-Loss Drug News / Lilly Registers Two Phase 3 Trials of EloraTZP, Its Eloralintide-Tirzepatide Combination

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Lilly Registers Two Phase 3 Trials of EloraTZP, Its Eloralintide-Tirzepatide Combination · GLP-1 Newspaper: Daily Ozempic, Zepbound & Weight-Loss Drug News

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  Welcome to the GLP-1 Newspaper, your daily update
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  on the news shaping GLP-1 and weight loss medications.
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  Visit glp1newspaper.com to see today's stories
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  and sign up for email alerts. So today we are
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  looking at Eli Lilly's registration of two phase
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  three trials for EloraTZP. Right, which is an
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  investigational once weekly co-formulation.
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  Yeah, of the amylin agonist eloralintide and
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  tirzepatide. Exactly. And we have the initial
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  details for both of these phase 3 trials
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  because they were first posted on a public registry
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  of clinical studies on October 19, 2026. Right.
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  And, you know, looking at the timeline for both
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  of these, they are not yet recruiting. No, not
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  yet. They are currently estimated to finish in
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  late 2029. And for both trials, they are going
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  to measure the percent change in body weight
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  at week 100. Yeah, that week 100 mark is the
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  primary focus. So looking at the first trial,
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  which is called AMPLIFY-1. Right. AMPLIFY-1 plans
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  for about 2,115 adults. And these are adults
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  with obesity and a BMI of 35 or more? Exactly.
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  And importantly, this specific trial is for individuals
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  without diabetes. Yeah, that is a key detail
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  for AMPLIFY-1. And it has five EloraTZP dose
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  arms. Right, plus an arm for tirzepatide alone.
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  And an arm for eloralintide alone. Yeah. And
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  finally, a placebo arm. So there are quite a
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  few arms in that first trial. Then there is the
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  second trial, AMPLIFY-2. Right. And AMPLIFY-2
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  plans for about 1,000 adults. With obesity or
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  overweight and type 2 diabetes. Yeah. And the
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  design here is different because AMPLIFY-2 compares
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  EloraTZP with tirzepatide alone. Right.
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  And it has no placebo arm. Exactly. No placebo
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  arm for that one. So to get some context for
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  these phase 3 registrations, I think we should
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  look back at the phase 2b trial data. Right.
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  From September 2026. Yeah. That trial had 367
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  adults with type 2 diabetes. Over 48 weeks, right?
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  Yeah. But a really specific detail to note about
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  that phase 2b trial is how the medication was
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  administered. Oh, right. Because in that trial,
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  eloralintide and tirzepatide were given as separate
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  injections. Oh, right. Rather than as one combined
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  shot. Exactly. Administered separately. Well,
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  looking at the results, there was up to 23.3%
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  weight loss with EloraTZP. Versus 14.8%
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  with tirzepatide 15 milligrams. And 3.0% with
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  the placebo. I should interject here just to
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  state plainly that those weight figures assume
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  everyone stayed on treatment. Right. That is
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  how those specific figures are calculated. And
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  we also need to state that the comparisons with
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  tirzepatide alone were secondary endpoints in
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  arms of about 37 people. Yeah, so just keeping
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  that specific sample size in mind. The trial
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  also measured A1C reductions. Right, which were
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  up to 2.9 with EloraTZP. Versus 2.4 with
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  tirzepatide. Well, I do want to push back a little
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  on the efficacy numbers and bring your attention
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  to the adverse events. Right, the tolerability
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  side of the data. Because treatment discontinuations
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  due to adverse events ranged from 10.8% to
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  27.0% across the EloraTZP arms. And I
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  need to clarify that 27% was the rate in the
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  highest arm, not all patients. Right. But still,
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  that compares to a discontinuation rate of 2.9%
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  with tirzepatide. Yeah. And 16.7% with
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  the placebo. So what exactly was the nature of
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  these side effects? Well, they were mostly mild
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  to moderate gastrointestinal events during dose
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  escalation. Which actually brings us to a perspective
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  from the investor side. Oh, from Kevin Gade?
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  Yeah, Kevin Gade, chief operating officer of
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  Bahl and Gaynor, an investment firm that holds
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  Lilly shares. What did he say about it? He said,
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  quote, the outsized weight loss benefit is being
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  questioned relative to the discontinuation rates
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  and the reality that this is a dual drug regime.
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  Well, regarding the dose escalation, Lilly says
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  phase 3 will use an optimized escalation
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  schedule. Right, an optimized schedule going
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  forward. We also have some comments from Kenneth
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  Custer, president of Lilly's Cardiometabolic
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  Health Division. Yeah, he stated that he expects
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  the combination to offer the best balance of
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  efficacy, safety, and tolerability. He also noted
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  that it might produce greater weight loss than
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  retatrutide in later trials. And for some factual
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  context there, retatrutide's up to 28.3% weight
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  loss over 80 weeks came from a late-stage trial
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  in people without diabetes. Right. And, you know,
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  just looking at the broader space, Novo Nordisk's
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  CagriSema is an amylin combination under the
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  U.S. regulatory review. Yeah. We also heard
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  from Citi analyst Geoff Meacham about the Lilly
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  data. What were his thoughts? He said the findings
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  provide strong combination proof of concept and
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  broaden Lilly's cardiometabolic portfolio beyond
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  today's incretin standards. Right. He also noted
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  that achieving tirzepatide-like weight loss
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  in patients with type 2 diabetes is significant
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  because diabetes typically tempers treatment
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  efficacy. Yeah. So to wrap up today's reporting,
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  Morningstar analyst Karen Andersen said, if Lilly
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  can get a handle on the discontinuations and
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  GI tolerability issues, then I think this is
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  looking stronger than retatrutide as a high-efficacy
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  option for patients. Thanks for listening to
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  the GLP-1 Newspaper. This show is for information
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  only and is not medical advice, so always talk
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  to your doctor before starting, stopping, or
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  changing any medication. Visit glp1newspaper.com
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