1100 Participants Needed

VK2735 for Weight Loss in Type 2 Diabetes

Recruiting at 130 trial locations
MJ
Overseen ByMaris Johnson
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Viking Therapeutics, Inc.
Must be taking: Oral glycemic-lowering
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VK2735 to determine its effectiveness in helping people with Type 2 Diabetes lose weight. Participants will receive either varying doses of VK2735 or a placebo (a substance with no active drug) to compare outcomes. The study aims to assess the effectiveness and safety of VK2735 for weight loss. It seeks adults with Type 2 Diabetes who are overweight or obese and have stable diabetes management. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

You can continue taking your current diabetes medications, except for amylin analogues, DPP-4 inhibitors, GLP-1R agonists, or dual GLP-1/GIP receptor agonists. The trial does not specify if you need to stop other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that VK2735 is likely to be safe for humans?

Research shows that VK2735 is generally safe and well-tolerated. In an earlier study, participants took VK2735 once a week for 13 weeks, and most did not experience serious side effects.

While safety data from the current Phase 3 trial is not yet available, VK2735's progression to this stage suggests that earlier studies did not identify major safety issues. Phase 3 trials typically involve more participants to confirm a treatment's safety and efficacy. If VK2735 had serious safety problems, it likely would not have advanced to this phase.

Overall, VK2735 appears well-tolerated, but ongoing and future studies must continue to monitor participant responses.12345

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Researchers are excited about VK2735 for weight loss in type 2 diabetes because it offers a novel approach compared to existing treatments. Unlike traditional therapies like metformin or GLP-1 receptor agonists, VK2735 is administered as a once-weekly injection with varying doses, which may lead to improved patient compliance. This treatment works by targeting specific pathways in the body differently, potentially enhancing weight loss and glucose control more effectively. Additionally, the flexibility in dosing could provide a more tailored approach to individual patient needs, making it a promising option in managing type 2 diabetes.

What evidence suggests that VK2735 might be an effective treatment for weight loss in Type 2 Diabetes?

Research has shown that VK2735 holds promise for weight loss in people with Type 2 Diabetes. Recent studies found that up to 97% of those taking VK2735 lost at least 5% of their body weight. Additionally, up to 88% of participants lost 10% or more, a significant improvement compared to just 4% in the placebo group (a pill with no active ingredient). In this trial, participants will receive different doses of VK2735 or a placebo to further evaluate its effectiveness. These results suggest that VK2735 could be an effective option for managing weight in individuals with obesity and diabetes.13678

Are You a Good Fit for This Trial?

This trial is for adults with Type 2 Diabetes who are overweight or obese. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not be taking conflicting medications.

Inclusion Criteria

I have Type 2 Diabetes with an HbA1c level between 7% and 11%, and my treatment has been stable for the last 3 months.
I am 18 years old or older.
Body mass index (BMI) ≥27 kg/m2

Exclusion Criteria

I have had two high blood sugar readings above 270 mg/dL recently.
I have had or am planning to have a special procedure for weight loss or had a weight loss device removed in the last 6 months.
I have Type 1 diabetes or a history of severe diabetes complications, but not Type 2 diabetes.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VK2735 or placebo once weekly for weight management over 78 weeks

78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VK2735
Trial Overview The study tests VK2735's ability to manage weight in the context of Type 2 Diabetes. It's a phase 3 trial comparing VK2735 against a placebo over 78 weeks, with patients randomly assigned to either group in a double-blind manner.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Assignment (Dose #3)Experimental Treatment1 Intervention
Group II: Active Assignment (Dose #2)Experimental Treatment1 Intervention
Group III: Active Assignment (Dose #1)Experimental Treatment1 Intervention
Group IV: Placebo AssignmentPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Viking Therapeutics, Inc.

Lead Sponsor

Trials
7
Recruited
990+

Citations

VK2735Up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo. VK2735 demonstrated encouraging safety and ...
Oral GLP-1/GIP Dual Agonist VK2735 Achieves Up to 12% ...VK2735 achieved significant weight reduction, with up to 12.2% mean body weight loss from baseline over 13 weeks. The trial's exploratory cohort ...
News & EventsUp to 97% of subjects in the VK2735 treatment groups achieved ≥5% weight loss, compared with 10% for placebo, and up to 80% of subjects in ...
NCT07104500 | VK2735 for Weight Management Phase 3This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well ...
Viking Therapeutics Announces Positive Top-Line Results ...Up to 97% of subjects in the VK2735 treatment groups achieved ≥5% weight loss, compared with 10% for placebo, and up to 80% of subjects in ...
Abstract 4367152: VANQUISH-2: Phase 3, Randomized ...Conclusions: VANQUISH-2 will provide the first Phase 3 efficacy and safety data, including CM parameters, of the dual GIP/GLP-1 receptor agonist ...
News & EventsData from the study showed that 78% of VK2735-treated patients who were characterized as prediabetic at baseline had successfully shifted to ...
Viking Therapeutics Highlights Clinical Data from VK2735 ...In addition, up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo. Additionally, as ...
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