Weight LossPhase 2NCT06828055
VK2735 for Weight Management Phase 2 (Venture Oral Dosing)
A Phase 2 study testing VK2735 in people with Weight Loss, run by Viking Therapeutics, Inc. at 15 sites in United States.
Trial summary
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… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 15 sitesUnited States
- Study dates
- 18 Dec 2024to 15 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI <50 kg/m2
- Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
- BMI calculated at the Screening visit will be used to determine eligibility.
Who cannot join
- History of or current clinically significant medical or psychiatric 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
- Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
- Current or past diagnosis of chronic pancreatitis
- Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
- Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
- Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Viking Clinical Site #104
Austin, Texas, 78705
Viking Clinical Site #113
Butte, Montana, 59701
Viking Clinical Site #109
City of Saint Peters, Missouri, 63303
Viking Clinical Site #101
Clearwater, Florida, 33756
Viking Clinical Site #100
Indianapolis, Indiana, 46260
Viking Clinical Site #112
Kansas City, Missouri, 64131
Viking Clinical Site #103
Knoxville, Tennessee, 37909
Viking Clinical Site #105
Lake Forest, California, 96230
Viking Clinical Site #108
Largo, Florida, 33777
Viking Clinical Site #110
Louisville, Kentucky, 40213
Viking Clinical Site #114
Marrero, Louisiana, 70072
Viking Clinical Site #107
Ocoee, Florida, 34761
Viking Clinical Site #111
Peoria, Arizona, 85381
Viking Clinical Site #102
Port Orange, Florida, 32127
Viking Clinical Site #106
San Antonio, Texas, 78229
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
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.
- Conditions
- Weight Loss
- Being tested
- Placebo, VK2735
- Keywords
- Overweight Obese
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching Placebo to VK2735
VK2735Drug
Active Treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo Assignment | Placebo comparator | VK2735 (Placebo) administered Daily Receives: Drug: Placebo |
| Active Assignment (Dose #1) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily Receives: Drug: VK2735 |
| Active Assignment (Dose #2) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily Receives: Drug: VK2735 |
| Active Assignment (Dose #3) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily Receives: Drug: VK2735 |
| Active Assignment (Dose #4) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily Receives: Drug: VK2735 |
| Active Assignment (Dose #5) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily Receives: Drug: VK2735 |
| Active Assignment (Dose #6) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily Receives: Drug: VK2735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 Weeks
Secondary outcomes (1)
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
Measured: 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start18 Dec 2024
- Primary completion24 Jun 2025
- Study completion15 Aug 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viking Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828055
- Sponsor's protocol ID
- VK2735-202
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Dose Finding Study of VK2735 Oral Formulation for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
- ClinicalTrials.gov ID
- NCT06828055
- Acronym / sponsor ID
- VK2735-202
- Conditions
- Weight Loss
- Keywords
- Overweight Obese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo Assignment | Placebo comparator | Drug: PlaceboVK2735 (Placebo) administered Daily |
| Active Assignment (Dose #1) | Experimental | Drug: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| Active Assignment (Dose #2) | Experimental | Drug: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| Active Assignment (Dose #3) | Experimental | Drug: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| Active Assignment (Dose #4) | Experimental | Drug: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| Active Assignment (Dose #5) | Experimental | Drug: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
| Active Assignment (Dose #6) | Experimental | Drug: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- History of or current clinically significant medical or psychiatric 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
- Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
- Current or past diagnosis of chronic pancreatitis
- Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching Placebo to VK2735 | Drug | Placebo Assignment |
| VK2735Active Treatment | Drug | Active Assignment (Dose #1), Active Assignment (Dose #2), Active Assignment (Dose #3), Active Assignment (Dose #4), Active Assignment (Dose #5), Active Assignment (Dose #6) |
Primary outcome
Percent (relative) change from baseline in body weight after 13 weeks of treatment
Time frame: 13 Weeks
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
1 secondary outcome
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
Time frame: 13 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VK2735 in people with Weight Loss, run by Viking Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent (relative) change from baseline in body weight after 13 weeks of treatment (time frame: 13 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.