来源：Altimmune 385
2023年11月30日，altimmune在线公布了Pemvidutide治疗肥胖及超重的2期临床试验结果。Pemvidutide（研发编号ALT-801）是Altimmune公司开发的GLP-1/Gcg双受体激动剂，按周给药，用于治疗肥胖及超重。
该2期临床试验显示Pemvidutide的1.2mg、1.8mg、2.4mg三个剂量组在治疗48周后，减重幅度分别达到10.3%、11.2%、15.6%，而安慰剂仅为2.2%。在安全性方面，主要的不良反应为恶心、呕吐，大多为轻至中度。Pemvidutide对心率无明显影响，也不影响血糖。
| Primary Endpoint: Body weight |
Placebo (N=97) |
1.2 mg (N=98) |
1.8 mg (N=99) |
2.4 mg (N=97) |
|
| ∆ Bodyweight, all subjects | %, LSM (SE)1 | -2.2 (1.4) | -10.3 (1.4)*** | -11.2 (1.4)*** | -15.6 (1.4)*** |
| Responder Analyses |
Placebo (N=51) |
1.2 mg (N=70) |
1.8 mg (N=63) |
2.4 mg (N=56) |
|
| % Subjects w/ ≥5% weight loss | %2 | 17.6% | 68.6%**** | 76.2%**** | 83.9%**** |
| % Subjects w/ ≥10% weight loss | 3.9% | 42.9%**** | 49.2%**** | 71.4%**** | |
| % Subjects w/ ≥15% weight loss | 2.0% | 21.4%** | 28.6%*** | 51.8%**** | |
| % Subjects w/ ≥20% weight loss | 2.0% | 10.0% | 9.5% | 32.1%**** | |
|
Secondary Endpoints |
Placebo(N=50) |
1.2 mg (N=69) |
1.8 mg (N=58) |
2.4 mg (N=55) |
|
| ∆ Total cholesterol |
%, LSM (SE)3 |
-2.8 (2.0) | -11.6 (1.7)** | -13.1 (1.9)*** | -15.1 (2.0)*** |
| ∆ LDL cholesterol | -2.8 (4.1) | -6.2 (3.5) | -11.2 (3.8) | -9.9 (3.9) | |
| ∆ Triglycerides | +7.3 (4.6) | -21.7 (3.9)*** | -22.3 (4.3)*** | -34.9 (4.4)*** | |
| Blood Pressure and Heart Rate |
Placebo (N=97) |
1.2 mg (N=98) |
1.8 mg (N=99) |
2.4 mg (N=97) |
|
| ∆ Systolic BP |
mm Hg, LSM (SE)1 |
+3.5 (2.3) |
-2.3 (2.2) | -1.6 (2.2) | -4.6 (2.3) |
| ∆ Diastolic BP | +1.8 (1.4) | -2.1 (1.3) | -1.0 (1.3) | -2.9 (1.4) | |
| ∆ Heart rate |
bpm, LSM (SE)1 |
-1.4 (1.6) | 0.1 (1.5) | 3.1 (1.5) | 2.5 (1.6) |
| Primary Endpoint: Body weight |
Placebo (N=97) |
1.2 mg (N=98) |
1.8 mg (N=99) |
2.4 mg (N=97) |
|
| ∆ Bodyweight, all subjects | %, LSM (SE)1 | -2.2 (1.4) | -10.3 (1.4)*** | -11.2 (1.4)*** | -15.6 (1.4)*** |
| Responder Analyses |
Placebo (N=51) |
1.2 mg (N=70) |
1.8 mg (N=63) |
2.4 mg (N=56) |
|
| % Subjects w/ ≥5% weight loss | %2 | 17.6% | 68.6%**** | 76.2%**** | 83.9%**** |
| % Subjects w/ ≥10% weight loss | 3.9% | 42.9%**** | 49.2%**** | 71.4%**** | |
| % Subjects w/ ≥15% weight loss | 2.0% | 21.4%** | 28.6%*** | 51.8%**** | |
| % Subjects w/ ≥20% weight loss | 2.0% | 10.0% | 9.5% | 32.1%**** | |
|
Secondary Endpoints |
Placebo(N=50) |
1.2 mg (N=69) |
1.8 mg (N=58) |
2.4 mg (N=55) |
|
| ∆ Total cholesterol |
%, LSM (SE)3 |
-2.8 (2.0) | -11.6 (1.7)** | -13.1 (1.9)*** | -15.1 (2.0)*** |
| ∆ LDL cholesterol | -2.8 (4.1) | -6.2 (3.5) | -11.2 (3.8) | -9.9 (3.9) | |
| ∆ Triglycerides | +7.3 (4.6) | -21.7 (3.9)*** | -22.3 (4.3)*** | -34.9 (4.4)*** | |
| Blood Pressure and Heart Rate |
Placebo (N=97) |
1.2 mg (N=98) |
1.8 mg (N=99) |
2.4 mg (N=97) |
|
| ∆ Systolic BP |
mm Hg, LSM (SE)1 |
+3.5 (2.3) |
-2.3 (2.2) | -1.6 (2.2) | -4.6 (2.3) |
| ∆ Diastolic BP | +1.8 (1.4) | -2.1 (1.3) | -1.0 (1.3) | -2.9 (1.4) | |
| ∆ Heart rate |
bpm, LSM (SE)1 |
-1.4 (1.6) | 0.1 (1.5) | 3.1 (1.5) | 2.5 (1.6) |
1 MMRM (mixed model for repeated measures), 2 CMH (Cochran Mantel Haenszel), 3 ANCOVA (analysis of covariance)
*p < 0.05; ** p < 0.005, *** p < 0.001, ****p < 0.0001 compared with placebo
Summary of Safety and Tolerability
| Adverse events (AEs) |
Placebo (N=97) |
1.2 mg (N=98) |
1.8 mg (N=99) |
2.4 mg (N=97) |
|
| SAEs related to study drug | N (%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.0%)4 |
| All AEs leading to discontinuation | N (%) | 6 (6.2%) | 5 (5.1%) | 19 (19.2%) | 19 (19.6%) |
| Drug-related AEs leading to discontinuation | N (%) | 2 (2.1%) | 4 (4.1%) | 16 (16.2%) | 15 (15.5%) |
| Gastrointestinal AEs—mainly mild to moderate | |||||
| Nausea | N (%) | 11 (11.3%) | 25 (25.5%) | 59 (59.6%) | 50 (51.5%) |
| Vomiting | N (%) | 3 (3.1%) | 6 (6.1%) | 27 (27.3%) | 27 (27.8%) |
| Diarrhea | N (%) | 5 (5.2%) | 8 (8.2%) | 10 (10.1%) | 18 (18.6%) |
| Constipation | N (%) | 8 (8.2%) | 17 (17.3%) | 13 (13.1%) | 22 (22.7%) |
| Major Adverse Cardiac Events (MACE) | N (%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Cardiac AEs including arrhythmias | N (%) | 4 (4.1%) | 3 (3.1%) | 4 (4.0%) | 3 (3.1%) |
4 Vomiting
| Summary of Glycemic Control |
Placebo (N=50) |
1.2 mg (N=68) |
1.8 mg (N=58) |
2.4 mg (N=55) |
|||
| Fasting glucose | |||||||
| Baseline, mg/dL | mean (SE) | 95.5 (1.5) | 99.4 (1.4) | 101.6 (1.4) | 101.5 (1.6) | ||
| Week 48, mg/dL | mean (SE) | 95.2 (1.5) | 98.6 (1.7) | 100.6 (1.6) | 99.4 (2.0) | ||
| HbA1c | |||||||
| Baseline, % | mean (SE) | 5.6 (0.0) | 5.5 (0.0) | 5.5 (0.1) | 5.6 (0.0) | ||
| Week 48, % | mean (SE) | 5.5 (0.0) | 5.5 (0.0) | 5.6 (0.1) | 5.5 (0.1) | ||
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2023年11月30日，Altimmune在线公布了Pemvidutide治疗肥胖及超重的2期临床试验结果。Pemvidutide的2.4 mg剂量组在治疗48周后，减重幅度可达15.6%。
发布日期：2023-11-30 浏览数：384
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