A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 78-Week Efficacy and Safety Study of VK2735 Administered Subcutaneously for Weight Management in Participants With Type 2 Diabetes Who Are Obese, or Overweight

Plain English Summary

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2) is a Phase 3 clinical trial sponsored by Viking Therapeutics, Inc. studying Weight Loss. Tests a new drug, VK2735, to help people with Type 2 Diabetes lose weight. For adults with Type 2 Diabetes who are overweight or obese, aged 18 and older. Participation involves weekly injections and regular check-ups. Alternatives include diet and exercise, or other diabetes medications. The trial aims to enroll 1100 participants.

Official Summary

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight

Who Can Participate

Here is what you need to know about eligibility for this trial. Can join if you are 18 or older, have Type 2 Diabetes, and are overweight or obese. Can't join if you have had recent weight loss, surgery for weight loss, or certain medical conditions. Age: 18 years and older. Health: Have Type 2 Diabetes and a BMI of 27 or higher. This trial is studying Weight Loss, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much weight participants lose over 78 weeks, which helps patients understand if the treatment is effective. The specific primary outcome measures are: Percent change in body weight from baseline to Week 78 in body weight (78 Weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial is important as it aims to fill a gap in treatment options for weight loss in people with Type 2 Diabetes. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Weight Loss, where improved treatment options are needed.

Investor Insight

The market for weight loss treatments for Type 2 Diabetes is large, with this trial potentially offering a new option that could compete with existing medications. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1100 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have any questions about the study or if you are eligible to participate. Participation involves weekly injections and regular check-ups at one of the study sites. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 1,100 participants

Interventions

• DRUG: VK2735 — VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly

Primary Outcomes

• Percent change in body weight from baseline to Week 78 in body weight (78 Weeks)

Secondary Outcomes

• Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment (78 Weeks)

Full Eligibility Criteria

Inclusion Criteria:

1. Age ≥18 years of age at the time of signing the informed consent
2. Body mass index (BMI) ≥27 kg/m2
3. Have Type 2 Diabetes Mellitus according to the American Diabetes Association with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Type 2 diabetes mellitus may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling), EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists

Exclusion Criteria:

1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
2. Self-reported body weight change of 5% or more within 3 months of screening
3. Have a prior or planned surgical treatment for obesity (except for liposuction or abdominoplasty if performed \>1 year prior to screening)
4. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
5. Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 diabetes mellitus (T2DM)
6. Have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening

   • Note: Severe hypoglycemia episodes should be considered when severe cognitive impairment requiring the assistance of another person occurs and the administration of carbohydrate, glucagon, or other resuscitative actions are required. Blood glucose (BG) measurements may not be available during such an event, but neurological recovery attributable to the restoration of BG to normal is considered sufficient evidence that the event was induced by a low BG concentration. If BG measurements are available, the levels associated with severe hypoglycemia are BG \< 54 mg/dL
7. Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \> 270 mg/dL (on 2 non-consecutive days) within 4 weeks prior to randomization
8. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
9. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
10. History of acute or chronic pancreatitis
11. Thyroid disease that is not controlled (Thyroid stimulating hormone (TSH) outside normal range by central lab at screening; one repetition during screening is allowed). Participants with previous history of partial/total thyroidectomy or hypothyroidism may be included, provided their hormone replacement dose has been stable for 3 months prior to screening

Trial Locations

• Viking Clinical Site #2037, Birmingham, Alabama, United States
• Viking Clinical Site #2064, Birmingham, Alabama, United States
• Viking Clinical Site #2128, Huntsville, Alabama, United States
• Viking Clinical Site #2005, Chandler, Arizona, United States
• Viking Clinical Site #2017, Flagstaff, Arizona, United States
• Viking Clinical Site #2018, Peoria, Arizona, United States
• Viking Clinical Site #2135, Scottsdale, Arizona, United States
• Viking Clinical Site #2019, Tucson, Arizona, United States
• Viking Clinical Site #2036, Little Rock, Arkansas, United States
• Viking Clinical Site #2071, Chula Vista, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Type 2 Diabetes
• Obesity
• Weight Management
• Diabetes Complications
• Endocrine Disorders
• Metabolic Disorders
• Obstructive Sleep Apnea
• Cardiovascular Diseases
• Hypertension

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