The Overview
AbbVie announced detailed Phase 1 data for ABBV-295, an investigational long-acting amylin analog, presented at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting. The study, involving 60 participants with a mean BMI of 29.3 kg/m2, evaluated the tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295. Key findings showed a favorable tolerability profile, with GI adverse events being predominantly mild. ABBV-295 demonstrated an approximately 11- to 12-day half-life and dose-proportional increases in plasma exposure, supporting evaluation of dosing intervals beyond weekly, including every-other-week and monthly regimens. Meaningful body weight reductions were observed across all evaluated dosing regimens, ranging from -7.8% to -9.8% at Week 12/13, compared to -0.3% for placebo. These results support advancing ABBV-295 into Phase 2 development for chronic weight management.
Knolens Analysis
At a Glance
| Indication | Obesity |
| Drug | ABBV-295 |
| Mechanism of Action | Amylin analog |
| Company | AbbVie |
| Trial Phase | Phase 1 |
| NCT ID | NCT06144684 |
| Category | Clinical Trial Event |
| Sub Category | Topline Results Positive |
| Therapeutic Area | Endocrinology & Metabolic Diseases |
| Conference Name | European Association for the Study of Diabetes (EASD) 2026 Annual Meeting |
| Presentation Date | September 30, 2026 |
| Patient Population | Adults with BMI 27.0 to 35.0 kg/m2 |
| Number of Participants | 60 (Part 2B/2C) |
| Dosing Regimens Evaluated | Once weekly, every-other-week, monthly |
| Mean Half-life | 10.7 to 12.3 days |
| Body Weight Reduction (Range) | -7.8% to -9.8% (at Week 12/13) |
| Placebo Body Weight Reduction | -0.3% |
| Most Common AEs (>20%) | Decreased appetite, fatigue, headache, nausea, diarrhea |
| Study Design | Randomized, placebo-controlled, multiple ascending dose study |
AbbVie's ABBV-295 Phase 1 Data Shows Favorable PK and Weight Loss
AbbVie announced detailed Phase 1 data for ABBV-295, an investigational long-acting amylin analog, presented at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting. The study, involving 60 participants with a mean BMI of 29.3 kg/m2, evaluated the tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295. Key findings showed a favorable tolerability profile, with GI adverse events being predominantly mild. ABBV-295 demonstrated an approximately 11- to 12-day half-life and dose-proportional increases in plasma exposure, supporting evaluation of dosing intervals beyond weekly, including every-other-week and monthly regimens. Meaningful body weight reductions were observed across all evaluated dosing regimens, ranging from -7.8% to -9.8% at Week 12/13, compared to -0.3% for placebo. These results support advancing ABBV-295 into Phase 2 development for chronic weight management.
- ABBV-295 demonstrated a robust pharmacokinetic profile, including a mean half-life of 10.7 to 12.3 days and dose-proportional increases in plasma exposure. This profile supports the feasibility of extended dosing intervals, such as every-other-week and monthly regimens, which could significantly enhance patient convenience and adherence for long-term chronic weight management.
- The investigational therapy exhibited a favorable tolerability and safety profile, with no serious treatment-emergent adverse events reported. Gastrointestinal adverse events, such as nausea (33.3% vs 20.0% placebo) and diarrhea (20.0% vs 0.0% placebo), were predominantly mild, occurred mainly during the first six weeks, and led to infrequent discontinuations (4.4% vs 0.0% placebo).
- ABBV-295 achieved clinically meaningful and dose-dependent reductions in body weight across all evaluated dosing regimens. At Week 12 or 13, participants experienced least-squares mean body weight reductions ranging from -7.8% to -9.8% for weekly, every-other-week, and monthly cohorts, significantly outperforming the -0.3% reduction observed in the placebo group.
Frequently Asked Questions
What is the mechanism of action of ABBV 295?
ABBV-295 is an investigational, oral, selective, non-covalent, and reversible Bruton's tyrosine kinase (BTK) inhibitor. By inhibiting BTK, ABBV-295 modulates B-cell receptor signaling, which is crucial for B-cell development, activation, and survival. This action aims to suppress pathogenic B-cell activity and downstream inflammatory processes implicated in various autoimmune diseases.
Does AbbVie have a GLP-1?
AbbVie does not currently have a marketed GLP-1 receptor agonist in its portfolio. While the company previously investigated an oral GLP-1 receptor agonist, ABT-204, for type 2 diabetes, it was discontinued after Phase 2 development. Their current pipeline does not feature a GLP-1 agonist in late-stage development.
What is amylin for weight loss?
Amylin is a neuroendocrine hormone co-secreted with insulin from pancreatic beta-cells, involved in glucose homeostasis and satiety signaling. For weight loss, amylin and its synthetic analogs, such as pramlintide, act centrally to reduce appetite and food intake, and peripherally by slowing gastric emptying. This dual mechanism promotes satiety, reduces postprandial glucose excursions, and ultimately leads to decreased caloric intake. Novel amylin receptor agonists are under development, often in combination with GLP-1 agonists, to enhance weight loss efficacy.
What is the new drug for obesity?
The new drug for obesity is Zepbound (tirzepatide), which received FDA approval in November 2023 for chronic weight management. Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. Clinical trials demonstrated superior weight loss compared to placebo and other GLP-1 agonists, establishing it as a significant new therapeutic option.
What are the newest treatments for obesity?
The newest treatments for obesity primarily involve highly effective GLP-1 receptor agonists like semaglutide (Wegovy) and the dual GIP/GLP-1 receptor agonist tirzepatide (Zepbound), which have demonstrated significant weight loss in clinical trials. These agents work by mimicking natural incretin hormones, enhancing satiety, slowing gastric emptying, and improving metabolic parameters. Further advancements include investigational multi-agonists, such as the GIP/GLP-1/glucagon receptor agonist retatrutide, which are showing even greater efficacy in late-stage development.
What is known as the "poor man's Ozempic"?
Metformin is colloquially known as the "poor man's Ozempic." This refers to its status as an older, generic, and significantly more affordable oral medication for type 2 diabetes, which can also induce modest weight loss. While not a GLP-1 receptor agonist, its accessibility and some shared metabolic benefits make it a more economical option for patients seeking glycemic control and potential weight reduction compared to newer, expensive injectables.
What new weight-loss drugs are coming in 2026?
Several late-stage pipeline assets are anticipated to launch by 2026, expanding the weight-loss therapeutic landscape. Key candidates include Eli Lilly's retatrutide, a GIP/GLP-1/glucagon triple agonist, and the oral GLP-1 receptor agonist orforglipron. Novo Nordisk's cagrisema, a fixed-dose combination of semaglutide and the amylin analog cagrilintide, is also a strong contender. These agents represent advancements in multi-hormonal agonism and oral delivery, offering new options for obesity management.
When will retatrutide be available?
Retatrutide is not yet commercially available. It is currently undergoing Phase 3 clinical development for obesity and related metabolic conditions. Commercial availability will depend on successful trial completion and subsequent regulatory approvals from agencies such as the FDA.
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