AbbVie has announced positive topline results1 from the multiple ascending dose (MAD) part of its phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2.
ABBV-295 is a long-acting amylin analogue that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.
Study enrolment mostly comprised male participants (88.3%). Different doses (2-14 mg), titrations and dose frequencies were tested in the study.
ABBV-295 was generally well tolerated across all dose levels evaluated. The most commonly reported adverse events were gastrointestinal disorders, which were mostly mild, and predominantly occurred during the first six weeks of treatment.1
ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week five), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.1
Results from the single ascending doses (SAD) part and other cohorts from the MAD part of the study were announced previously. Full data from the study will be presented at a future scientific conference.
Summary of Phase 1 MAD Study Key Results1 (Percent Change from Baseline in Body Weight at Week 12 and Week 13)
| Cohorta | LS Mean (95% CI) at week 12b | LS Mean (95% CI) at week 13b |
| All Placebo | -0.26 (-1.89, 1.37) | -0.25 (-1.88, 1.38) |
| Cohort 3 (weekly dosing) | -7.75 (-9.89, -5.61) | – |
| Cohort 4 (weekly dosing) | -8.70 (-10.75, -6.65) | – |
| Cohort 5a (weekly dosing) | -9.79 (-11.99, -7.59) | – |
| Cohort 5b (every other week dosing) | -7.76 (-9.82, -5.70) | -9.73 (-11.79, -7.67) |
| Cohort 6 (monthly dosing after week 5) | -6.74 (-8.70, -4.79) | -7.86 (-9.80, -5.91) |
| a Doses from 2mg to 14mg were tested using different dose escalations and dosing frequencies. |
| b LS mean estimates were derived using a Mixed Model for Repeated Measures (MMRM). Participants were required to adhere to the dosing plan and those unable to continue treatment were withdrawn from the study with no further efficacy data collected. |
Phase 1 GUC17-01 study
The phase 1 clinical trial is a two-part, single center, double-blind (within cohorts), randomised, placebo-controlled, single (part 1) and multiple (part 2) ascending dose study of subcutaneous ABBV-295 (GUB014295). A total of 76 participants were enrolled in the MAD study.
References
- AbbVie Data on File: ABVRRTI82837
- A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06144684?intr=GUB014295&rank=1#participation-criteria. Accessed March 3, 2026.
