Weight LossPhase 3NCT07868939
Oral VK2735 for Weight Management in Adults With Type 2 Diabetes Mellitus Phase 3 (SUNRISE 2)
A Phase 3 study testing VK2735 Oral in people with Weight Loss, run by Viking Therapeutics, Inc..
Trial summary
This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) adults with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- VK2735 Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age at the time of signing the informed consent.
- Body mass index (BMI) ≥ 27 kg/m2
- Have Type 2 Diabetes Mellitus according to the American Diabetes Association (See Section 12.5), with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Participants with HbA1c between 6.5%-6.9% or 11.0%-11.5% are allowed to have a single HbA1c retesting to confirm eligibility. 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.
Who cannot join
- History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation
- Self-reported body weight change of 5% or more within 3 months of screening
- Have a prior or planned surgical treatment for obesity such as a gastric sleeve, lap band or any form of bariatric surgery (except for liposuction or abdominoplasty if performed >1 year prior to screening)
- 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)
- Have Type 1 Diabetes Mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except Type 2 Diabetes Mellitus (T2DM)
- Have had 1 or more episodes of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months of screening
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- 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.
- 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
- Have non-proliferative diabetic retinopathy that requires acute treatment OR diabetic macular edema OR proliferative diabetic retinopathy identified during a dilated fundoscopy examination performed within 3 months of screening. Please see Section 7.6.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- History of acute or chronic pancreatitis
- 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 and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 68-Week Efficacy and Safety Study of VK2735 Administered Orally for Weight Management in Participants With Type 2 Diabetes Mellitus Who Are Obese, or Overweight
This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) adults with Type 2 Diabetes Mellitus.
Read the detailed description
This is a Phase 3, multicenter, 68-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 oral formulation in adults with Type 2 Diabetes Mellitus (T2DM) who are obese or overweight.
- Conditions
- Weight Loss
- Being tested
- VK2735 Oral, Placebo Comparator
- Keywords
- body weight changes, body weight, weight loss
- Medical subject headings
- Weight Loss, Body Weight Changes, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK2735 OralDrug
VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily
Placebo ComparatorDrug
Placebo comparator administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo Assignment | Placebo comparator | Placebo comparator orally once daily Receives: Drug: Placebo Comparator |
| Active Assignment (Dose 1) | Experimental | VK2735 Dose level 1 orally once daily Receives: Drug: VK2735 Oral |
| Active Assignment (Dose 2) | Experimental | VK2735 Dose level 2 orally once daily Receives: Drug: VK2735 Oral |
| Active Assignment (Dose 3) | Experimental | VK2735 Dose level 3 orally once daily Receives: Drug: VK2735 Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight for participants with type 2 diabetes mellitus receiving VK2735 orally once daily
To demonstrate that VK2735 daily oral is superior to placebo for percent change in body weight from baseline to week 68
Measured: 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viking Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868939
- Sponsor's protocol ID
- VK2735-305
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No