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This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
VK2735 or matched placebo will be administered once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Assignment | Placebo Comparator | VK2735 (Placebo) administered Daily |
|
| Active Assignment (Dose #1) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
|
| Active Assignment (Dose #2) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
|
| Active Assignment (Dose #3) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
|
| Active Assignment (Dose #4) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
|
| Active Assignment (Dose #5) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching Placebo to VK2735 |
| |
| VK2735 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent (relative) change from baseline in body weight after 13 weeks of treatment | To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment | To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events, incidence of Treatment-Emergent Serious Adverse Events and incidence of Adverse Events of Special Interest | To evaluate the safety and tolerability of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition | 13 Weeks |
Inclusion Criteria:
Age ≥18 years of age at the time of signing the informed consent.
Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI <50 kg/m2
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viking Clinical Site #111 | Peoria | Arizona | 85381 | United States | ||
| Viking Clinical Site #105 |
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|
| Active Assignment (Dose #6) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
|
| Drug |
Active Treatment |
|
| Lake Forest |
| California |
| 96230 |
| United States |
| Viking Clinical Site #101 | Clearwater | Florida | 33756 | United States |
| Viking Clinical Site #108 | Largo | Florida | 33777 | United States |
| Viking Clinical Site #107 | Ocoee | Florida | 34761 | United States |
| Viking Clinical Site #102 | Port Orange | Florida | 32127 | United States |
| Viking Clinical Site #100 | Indianapolis | Indiana | 46260 | United States |
| Viking Clinical Site #110 | Louisville | Kentucky | 40213 | United States |
| Viking Clinical Site #114 | Marrero | Louisiana | 70072 | United States |
| Viking Clinical Site #109 | City of Saint Peters | Missouri | 63303 | United States |
| Viking Clinical Site #112 | Kansas City | Missouri | 64131 | United States |
| Viking Clinical Site #113 | Butte | Montana | 59701 | United States |
| Viking Clinical Site #103 | Knoxville | Tennessee | 37909 | United States |
| Viking Clinical Site #104 | Austin | Texas | 78705 | United States |
| Viking Clinical Site #106 | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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