AbbVie starts Phase 2 trial of amylin analog ABBV-295
A Phase 2 trial has begun for an obesity drug that works through amylin rather than GLP-1, though its early data came mostly from men whose average BMI was below 30.
AbbVie has started a Phase 2 clinical trial of ABBV-295, an experimental amylin analog being developed for obesity, and its partner Gubra said it received a milestone payment because that trial began [1]. Gubra announced the milestone on Aug. 26, 2026 [1]. The amount of the payment has not been disclosed [1].
ABBV-295, also called GUB014295, is a long-acting version of amylin, a hormone involved in satiety. It is given as a subcutaneous injection and works by activating amylin and calcitonin receptors — a mechanism the companies describe as distinct from incretin-based therapies such as GLP-1 and GIP receptor agonists [1]. It has not been approved by any regulatory authority [1].
What the Phase 1 data showed
The Phase 2 start follows Phase 1 results AbbVie reported in March 2026 [1]. In the multiple-ascending-dose part of that study, 76 adults received ABBV-295 or placebo for 12 to 13 weeks. Doses ranged from 2 mg to 14 mg, with different dose escalations and dosing frequencies tested [1].
Weight loss was dose-dependent. For weekly dosing groups, the average (least-squares mean) change in body weight ranged from -7.75% to -9.79% at week 12. For an every-other-week group and a monthly-dosing group after week 5, the range was -7.86% to -9.73% at week 13. Placebo groups lost -0.26% at week 12 and -0.25% at week 13 [1].
By cohort, week-12 changes were -7.75%, -8.70% and -9.79% for the three weekly groups, -7.76% for the every-other-week group and -6.74% for the monthly group. At week 13, the every-other-week group was at -9.73% and the monthly group at -7.86% [1].
No serious adverse events were reported. The most commonly reported side effects were gastrointestinal, mostly mild, and occurred mainly during the first six weeks of treatment [1].
The study population is worth noting. Participants had a mean body mass index below 30 kg/m2 — under the level generally used for an obesity diagnosis — and 88.3% were male [1]. It has not been reported whether similar weight loss would appear in a broader group. Participants who could not follow the dosing plan were withdrawn from the study, and no further efficacy data were collected from them [1].
Under a license agreement signed in March 2025, AbbVie leads development and commercialization of ABBV-295 worldwide. Gubra is eligible for up to $1.875 billion in development, commercial and sales milestone payments, plus tiered royalties on global net sales [1]. Gubra, based in Denmark, reported revenue of DKK 2.6 billion (about $400 million) in 2025 [1].
Why it matters for patients
The injectable weight-loss drugs most patients know are incretin-based, meaning they act on GLP-1 or GIP receptors [1]. ABBV-295 works through amylin and calcitonin receptors instead [1]. The companies describe it as potentially differentiated for chronic weight management, a positioning that matters if it eventually offers another route for people who do not tolerate or do not respond well to incretin drugs [1].
Several practical questions have no answers yet. There is no head-to-head data comparing ABBV-295 with any approved obesity drug; the Phase 1 comparison was against placebo [1]. Nothing has been disclosed about pricing, insurance coverage or how the drug would be supplied if approved. And approval is not assured — Phase 2 is an early step, and ABBV-295 remains investigational [1].
What happens next
The Phase 2 trial is now underway, but its design, size, endpoints and expected completion date have not been reported [1]. Full Phase 1 data are to be presented at a future scientific conference, with no date announced [1]. Gubra has not disclosed the size or terms of the milestone payment it received [1].
Sources
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