Pharmacokinetic and dose‐finding studies on efpeglenatide in patients with type 2 diabetes
Bibliographic record
Abstract
Abstract Aim To assess the efficacy, safety and pharmacokinetic/pharmacodynamic properties of efpeglenatide, a long‐acting glucagon‐like peptide‐1 receptor agonist, in patients with type 2 diabetes (T2D). Research design and methods Two randomized, double‐blind, placebo‐controlled phase 2 trials were conducted. The single‐dose study ( n = 48) was a first‐in‐patient, sequential dose‐escalation study. Patients received a single subcutaneous injection of efpeglenatide (2–100 μg/kg) or placebo. The repeated‐dose study ( n = 71) was a multiple‐ascending‐dose trial. Patients received weekly (1, 2 or 4 mg once weekly; 8‐week period) or monthly (8, 12 or 16 mg once monthly; 9‐week period) subcutaneous injections of efpeglenatide or placebo (without titration). Results Both studies demonstrated dose‐proportional increases in efpeglenatide serum concentrations. The median time to attain maximum serum concentration (t max ) for efpeglenatide ranged from 72 to 144 hours in the single‐dose study and from 48 to 120 hours in the repeated‐dose study (following final dose). Geometric mean t 1/2 ranged from 135 to 180 hours across studies. Peak‐to‐trough ratios in the repeated‐dose study ranged from 1.3 to 1.4 with once‐weekly dosing and from 5.9 to 12.9 with once‐monthly dosing. Following a single dose of efpeglenatide 14–100 μg/kg, fasting plasma glucose and postprandial plasma glucose levels were decreased at week 1 and remained below baseline levels for ≥3 weeks post‐dosing. Repeated doses of efpeglenatide led to significant reductions in glycated haemoglobin vs placebo. In both studies, efpeglenatide was generally well tolerated. Gastrointestinal disorders were the most frequently reported treatment‐emergent adverse events in efpeglenatide‐treated patients. Conclusions The delayed t max, long half‐life, and low peak‐to‐trough ratios observed demonstrate potential for improved efficacy and dosing flexibility, with good tolerability of efpeglenatide in patients with T2D.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".