AbbVie's amylin analog ABBV-295 posts positive Phase 1 results

AbbVie said on March 9, 2026, that its experimental drug ABBV-295 produced dose-dependent weight loss of up to about 10% after 12 to 13 weeks in a Phase 1 study, and that no serious side effects were reported ^[1]. The company also moved up the start of Phase 2 testing to the third quarter of 2026 ^[2].

ABBV-295 is a long-acting amylin analog originally developed by the Danish biotech Gubra and licensed to AbbVie. Unlike Ozempic, Wegovy, Mounjaro, Zepbound or Foundayo, which work on GLP-1 or GIP incretin receptors, ABBV-295 activates amylin and calcitonin receptors, a mechanism AbbVie describes as "mechanistically distinct" from incretin-based drugs ^[1].

The multiple ascending dose study enrolled 76 adults with a mean BMI under 30 — meaning most participants were not classified as having obesity — and was 88.3% male ^[1]. Doses from 2 mg to 14 mg were tested with different titration schedules and dosing frequencies, including weekly, every-other-week, and monthly injections ^[1]. At week 12, weekly-dosed groups showed least-squares mean weight loss ranging from 7.75% to 9.79%, compared with a 0.26% loss in the placebo group ^[1]. Groups dosed every other week or monthly after an initial titration period showed losses of 7.86% to 9.73% at week 13, versus 0.25% for placebo ^[1]. AbbVie noted that comparable weight loss was seen with both every-other-week and monthly dosing, according to Gubra ^[2].

The most common side effects were gastrointestinal, mostly mild, and occurred largely in the first six weeks of treatment ^[1]. AbbVie called the tolerability profile "favorable" across all dose levels tested ^[1]. No numeric rates of nausea, vomiting or other specific side effects were disclosed in the release.

Why it matters for patients

For people currently using or considering GLP-1 drugs, ABBV-295 represents an early-stage alternative built on a different biological pathway. Amylin is a hormone involved in satiety and slowing stomach emptying, and AbbVie is testing whether an amylin-based drug can rival the weight loss seen with incretin drugs while potentially offering a different tolerability profile ^[1]. However, these results come from a small, short study in a population that was mostly male and, on average, did not have obesity by BMI standards ^[1]. Whether similar results would hold in a more typical population of patients with obesity, over a longer treatment period, is not yet known. AbbVie has not disclosed exact rates of nausea or other gastrointestinal symptoms, only that they were "mostly mild" ^[1]. The drug has not been approved anywhere, and its safety and effectiveness remain unestablished ^[1].

What happens next

AbbVie has already accelerated its timeline, with Gubra saying in a May 6, 2026, trading statement that AbbVie is expected to begin Phase 2 testing in the third quarter of 2026 ^[2]. Public trial registries show a Phase 2 dose-finding study, NCT07752979, planned to enroll about 360 participants with obesity or overweight and weight-related health conditions at roughly 70 sites in the United States and Puerto Rico, with a start date of August 3, 2026 ^[2]. That trial is designed to measure weight change at week 32 and will run participants through a 52-week double-blind treatment period ^[2]. AbbVie is also running smaller studies, including a pharmacokinetics trial in Japanese adults that started March 30, 2026, and a completed drug-interaction study evaluating ABBV-295 alongside oral contraceptives ^[2]. Full data from the Phase 1 study are expected to be presented at a future scientific conference ^[1].