Weight LossPhase 2VENTURENCT06068946
VK2735 for Weight Management Phase 2
A Phase 2 study testing VK2735 in people with Weight Loss, run by Viking Therapeutics, Inc. at 20 sites in United States.
Trial summary
This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one… 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
- 176 participants
- Where
- 20 sitesUnited States
- Study dates
- 31 Aug 2023to 2 Apr 2024
- 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
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 ≥20 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
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Viking Clinical Site #101
Austin, Texas, 78705
Viking Clinical Site #118
Austin, Texas, 78731
Viking Clinical Site #119
Birmingham, Alabama, 35235
Viking Clinical Site #111
Butte, Montana, 59701
Viking Clinical Site #116
Clearwater, Florida, 33756
Viking Clinical Site #106
Clearwater, Florida, 33761
Viking Clinical Site #104
Indianapolis, Indiana, 46260
Viking Clinical Site #112
Jacksonville, Florida, 32216
Viking Clinical Site #102
Kansas City, Missouri, 64131
Viking Clinical Site #108
Knoxville, Tennessee, 37920
Viking Clinical Site #114
Long Beach, California, 90815
Viking Clinical Site #110
Los Angeles, California, 90057
Viking Clinical Site #103
Louisville, Kentucky, 40213
Viking Clinical Site #109
Marrero, Louisiana, 70072
Viking Clinical Site #105
Ocoee, Florida, 34761
Viking Clinical Site #100
Phoenix, Texas, 85210
Viking Clinical Site #107
Port Orange, Florida, 32127
Viking Clinical Site #115
San Antonio, Texas, 78229
Viking Clinical Site #117
San Antonio, Texas, 78229
Viking Clinical Site #113
Tustin, California, 92780
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of VK2735 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 study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 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 weekly.
- Conditions
- Weight Loss
- Being tested
- VK2735, Placebo
- Keywords
- Overweight, Obese
- Medical subject headings
- Weight Loss, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK2735Biological
VK2735 is a peptide GLP-1 and GIP dual agonist
PlaceboBiological
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| VK2735 (Placebo) | Placebo comparator | Placebo Receives: Biological: Placebo |
| VK2735 (Dose #1) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist Receives: Biological: VK2735 |
| VK2735 (Dose #2) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist Receives: Biological: VK2735 |
| VK2735 (Dose #3) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist Receives: Biological: VK2735 |
| VK2735 (Dose #4) | Experimental | VK2735 is a peptide GLP-1 and GIP dual agonist Receives: Biological: VK2735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (relative) change from baseline to Week 13 in body weight
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
Measured: 13 weeks
Secondary outcomes (1)
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13
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
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 posted5 Oct 2023
- Study start31 Aug 2023
- Primary completion27 Feb 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 176 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
- NCT06068946
- Sponsor's protocol ID
- VK2735-201
- Acronym
- VENTURE
- Status last verified
- Dec 2024
- First submitted
- 28 Sep 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bays HE, Toth P, Alkhouri N, Pullman J, Freilich B, Neutel J, Ji S, Stubbe S, Hedges P, Lian B. Weekly Subcutaneous VK2735, a GIP/GLP-1 Receptor Dual Agonist, for Weight Management: Phase 2, Randomized, 13-Week VENTURE Study. Obesity (Silver Spring). 2026 Mar;34(3):537-549. doi: 10.1002/oby.70106. Epub 2026 Jan 8.
PubMed 41508550
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 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 Study of VK2735 for Weight Management in Subjects Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
- ClinicalTrials.gov ID
- NCT06068946
- Acronym / sponsor ID
- VENTURE / VK2735-201
- Conditions
- Weight Loss
- Keywords
- Overweight, Obese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 5 Oct 2023 (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 study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 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 weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VK2735 (Placebo) | Placebo comparator | Biological: PlaceboPlacebo |
| VK2735 (Dose #1) | Experimental | Biological: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist |
| VK2735 (Dose #2) | Experimental | Biological: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist |
| VK2735 (Dose #3) | Experimental | Biological: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist |
| VK2735 (Dose #4) | Experimental | Biological: VK2735VK2735 is a peptide GLP-1 and GIP dual agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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 ≥20 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 |
|---|---|---|
| VK2735VK2735 is a peptide GLP-1 and GIP dual agonist | Biological | VK2735 (Dose #1), VK2735 (Dose #2), VK2735 (Dose #3), VK2735 (Dose #4) |
| PlaceboPlacebo comparator | Biological | VK2735 (Placebo) |
Primary outcome
Percent (relative) change from baseline to Week 13 in body weight
Time frame: 13 weeks
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
1 secondary outcome
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13
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 12 Feb 2025.
- Derived from this study: PubMed 41508550Bays HE, Toth P, Alkhouri N, Pullman J, Freilich B, Neutel J, Ji S, Stubbe S, Hedges P, Lian B. Weekly Subcutaneous VK2735, a GIP/GLP-1 Receptor Dual Agonist, for Weight Management: Phase 2, Randomized, 13-Week VENTURE Study. Obesity (Silver Spring). 2026 Mar;34(3):537-549. doi: 10.1002/oby.70106. Epub 2026 Jan 8.
Related trials for Weight Loss
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
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.
20 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 20 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 2 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 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 to Week 13 in body weight (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06068946, which also lists 1 linked publication.
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 12 Feb 2025.