Research and trials

AstraZeneca opens three SELENE Phase 3 trials of AZD6234, one for people already on an incretin

AstraZeneca's SELENE program includes a 500-person Phase 3 study of AZD6234 added to an existing incretin drug, a question that matters to people already taking semaglutide or tirzepatide.

By the Semaglutides news desk·

AstraZeneca has opened three Phase 3 trials of AZD6234, an experimental amylin analog being developed for weight loss, including one designed around people who are already taking an incretin drug such as semaglutide or tirzepatide [1][2].

The program is called SELENE. SELENE 1 has a planned enrollment of 2,500 participants, SELENE 2 is aiming for 1,500, and SELENE 3, the smallest of the three, plans to enroll 500 [1][2]. All three opened within days of one another. One registered study describes its population as adults with obesity or overweight who also have a weight-related health condition, and who do not have type 2 diabetes [1].

SELENE 3 tests AZD6234 as an add-on for people who are already taking an incretin medication. That is the drug class that includes semaglutide (sold as Ozempic, Wegovy and Rybelsus) and tirzepatide (sold as Mounjaro and Zepbound) [1][2]. Most large weight-loss trials have enrolled people who were not taking an obesity medicine at the start. An add-on design asks a different question: whether a second drug from a different class adds benefit on top of what a person is already taking.

How each trial is set up beyond that has not been disclosed in the registrations. They do not list the comparison arms, the doses being tested, how long participants will be treated, or expected completion dates. No Phase 3 results for AZD6234 have been reported, so it is not known whether the drug helps people lose weight, how it compares with approved medicines such as Wegovy or Zepbound, or what side effects it causes.

AZD6234 is not approved for sale in the United States and remains in clinical testing [1]. Amylin analogs are a newer area of weight-loss research; the SELENE studies are the late-stage tests for this AstraZeneca candidate.

Why it matters for patients

Millions of Americans now take semaglutide or tirzepatide. A common question for them is what to do when weight loss slows or when side effects keep the dose lower than planned. There is no large trial evidence today on whether adding an amylin-class drug helps in that situation. SELENE 3 is one of the first Phase 3 efforts aimed at producing that evidence in people who are already on an incretin, which means its results would speak to a large and growing group of patients rather than to people starting treatment for the first time.

Eligibility matters here. At least one of the new trials excludes people with type 2 diabetes [1], so readers with diabetes may find they do not qualify for that study. Each trial sets its own rules, and the registrations for the other two studies list limited detail.

Nothing about these trials changes what is available today. AZD6234 is not an approved treatment, and no results from the Phase 3 program have been published [1].

What happens next

The three studies are open and together are seeking 4,500 participants [1][2]. The registrations do not list expected completion dates, and no date has been announced for when results will be reported.

Sources

  1. https://clinicaltrials.gov/study/NCT07784725
  2. https://clinicaltrials.gov/study/NCT07776509

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