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Also known as VK2735 Oral
VK2735 · 7 trials · 2 indications
To demonstrate that VK2735 daily oral is superior to placebo for percent change in body weight from baseline to week 68
To demonstrate that VK2735 daily oral is superior to placebo for percent change in body weight from baseline to week 68
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
To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition
To evaluate the safety and tolerability of single doses of subcutaneous injections of VK2735 in healthy participants
| Arm | Type | Description |
|---|---|---|
| Placebo Assignment | PLACEBO_COMPARATOR | Placebo comparator orally once daily |
| Active Assignment (Dose 1) | EXPERIMENTAL | VK2735 Dose level 1 orally once daily |
| Active Assignment (Dose 2) | EXPERIMENTAL | VK2735 Dose level 2 orally once daily |
| Active Assignment (Dose 3) | EXPERIMENTAL | VK2735 Dose level 3 orally once daily |
| Active Assignment (Dose #1) | EXPERIMENTAL | VK2735 7.5mg Once Weekly |
| Active Assignment (Dose #2) | EXPERIMENTAL | VK2735 12.5mg Once Weekly |
| Active Assignment (Dose #3) | EXPERIMENTAL | VK2735 17.5mg Once Weekly |
| 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 |
| Active Assignment (Dose #6) | EXPERIMENTAL | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| VK2735 (Placebo) | PLACEBO_COMPARATOR | Placebo |
| VK2735 (Dose #1) | EXPERIMENTAL | VK2735 is a peptide GLP-1 and GIP dual agonist |
| VK2735 (Dose #2) | EXPERIMENTAL | VK2735 is a peptide GLP-1 and GIP dual agonist |
| VK2735 (Dose #3) | EXPERIMENTAL | VK2735 is a peptide GLP-1 and GIP dual agonist |
| VK2735 (Dose #4) | EXPERIMENTAL | VK2735 is a peptide GLP-1 and GIP dual agonist |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered SC once in healthy participants |
| VK2735 (Part A) | EXPERIMENTAL | Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo administered SC once weekly for four weeks in healthy participants |
| VK2735 (Part B) | EXPERIMENTAL | Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants. |
| VK2735 (Part C ) | PLACEBO_COMPARATOR | Placebo administered orally daily for 28 days in healthy participants |
| VK2735 (Part C) | EXPERIMENTAL | Escalating doses of VK2735 administered daily (PO) in healthy participants. |
| Name | Type | Description |
|---|---|---|
| VK2735 | DRUG | VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily |
| Placebo comparator | DRUG | Placebo comparator administered orally once daily |
| VK2735 Oral | DRUG | VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily |
| Placebo | DRUG | Matching Placebo to VK2735 |
| VK2735 Placebo | DRUG | Administered orally |
| VK2735 Drug | DRUG | Administered orally |
Inclusion Criteria: 1. Age ≥18 years of age at the time of signing the informed consent. 2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated). * Weight-related co-morbid conditions include hypertension, dyslipidemia, obstruc...
VK2735 is an investigational small molecule being developed for weight loss, including weight management in adults with type 2 diabetes mellitus. It is in Phase 3 clinical development and is not yet approved for any indication. The program includes separate Phase 3 studies in weight management and in weight management with type 2 diabetes.
VK2735 targets the GLP-1 and GIP receptors. Both are receptors involved in metabolic signaling, and the drug is designed as a small molecule that acts on these two receptor targets. This dual receptor activity is the basis for its development in weight loss and weight management in adults with type 2 diabetes.
VK2735 is being developed by Viking Therapeutics, Inc., which trades under the ticker VKTX. Viking Therapeutics is the sponsor of the Phase 3 clinical program evaluating the drug for weight loss, including studies in adults with type 2 diabetes mellitus.
VK2735 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 3 program includes trials that are active and not recruiting as well as trials that are not yet recruiting, with a total of seven trials across completed and ongoing stages.
Phase 3 trials of VK2735 include NCT07104500 and NCT07104383, both active and not recruiting, and NCT07868939 (SUNRISE 2) and NCT07868835 (SUNRISE 1), both not yet recruiting. The program totals seven trials, four active and three completed, with 7,268 participants enrolled overall.
Yes, VK2735 Oral is another name for VK2735. Both refer to the same investigational small molecule developed by Viking Therapeutics for weight loss. The oral designation reflects the oral route of administration used in the Phase 3 weight management studies, including the SUNRISE 1 and SUNRISE 2 trials.