Weight LossPhase 3NCT07104383
VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)
A Phase 3 study testing VK2735 in people with Weight Loss, run by Viking Therapeutics, Inc. at 127 sites in 2 countries.
Trial 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 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
- 1,100 participants
- Where
- 127 sitesin 2 countries
- Study dates
- 23 Jun 2025to 1 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 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
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 (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
Show all 12Show fewer
- 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 proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
- 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
127 sites in 2 countries.
127 sites in 2 countries
United States125 sites
Viking Clinical Site #2047
Abilene, Texas, 79606
Viking Clinical Site #2088
Albany, New York, 12205
Viking Clinical Site #2029
Albuquerque, New Mexico, 87109
Viking Clinical Site #2098
Arlington, Virginia, 22205
Viking Clinical Site #2116
Atlanta, Georgia, 30329
Viking Clinical Site #2063
Austin, Texas, 78131
Viking Clinical Site #2007
Austin, Texas, 78705
Viking Clinical Site #2118
Baton Rouge, Louisiana, 70808
Viking Clinical Site #2139
Baton Rouge, Louisiana, 70809
Viking Clinical Site #2091
Bellaire, Texas, 77401
Viking Clinical Site #2037
Birmingham, Alabama, 35235
Viking Clinical Site #2064
Birmingham, Alabama, 35249
Viking Clinical Site #2124
Brownsville, Texas, 78526
Viking Clinical Site #2010
Butte, Montana, 59701
Viking Clinical Site #2005
Chandler, Arizona, 85210
Viking Clinical Site #2141
Charlotte, North Carolina, 28205
Viking Clinical Site #2094
Chevy Chase, Maryland, 20815
Viking Clinical Site #2006
Chicago, Illinois, 60607
Viking Clinical Site #2071
Chula Vista, California, 91911
Viking Clinical Site #2043
Cincinnati, Ohio, 45219
Viking Clinical Site #2074
Cincinnati, Ohio, 45242
Viking Clinical Site #2031
City of Saint Peters, Missouri, 63303
Viking Clinical Site #2013
Clearwater, Florida, 33756
Viking Clinical Site #2121
Clearwater, Florida, 33761
Viking Clinical Site #2044
Cleveland, Ohio, 44122
Viking Clinical Site #2030
Columbus, Georgia, 31904
Viking Clinical Site #2089
Columbus, Ohio, 43215
Viking Clinical Site #2003
Cooper City, Florida, 33024
Viking Clinical Site #2049
Dallas, Texas, 75230
Viking Clinical Site #2048
Dallas, Texas, 75235
Viking Clinical Site #2148
Dayton, Ohio, 45420
Viking Clinical Site #2112
DeLand, Florida, 32720
Viking Clinical Site #2107
Delray Beach, Florida, 33445
Viking Clinical Site #2119
Denver, Colorado, 80210
Viking Clinical Site #2045
East Greenwich, Rhode Island, 02818
Viking Clinical Site #2070
Escondido, California, 92025
Viking Clinical Site #2027
Fargo, North Dakota, 58104
Viking Clinical Site #2101
Fayetteville, North Carolina, 28304
Viking Clinical Site #2017
Flagstaff, Arizona, 86001
Viking Clinical Site #2083
Fort Myers, Florida, 33912
Viking Clinical Site #2111
Frisco, Texas, 75033
Viking Clinical Site #2026
Greensboro, North Carolina, 27410
Viking Clinical Site #2028
Greenville, South Carolina, 29607
Viking Clinical Site #2140
Gulfport, Mississippi, 39503
Viking Clinical Site #2096
Hartsdale, New York, 10530
Viking Clinical Site #2062
Honolulu, Hawaii, 96814
Viking Clinical Site #2046
Houston, Texas, 77040
Viking Clinical Site #2054
Huntington Park, California, 90255
Viking Clinical Site #2128
Huntsville, Alabama, 35801
Viking Clinical Site #2146
Indianapolis, Indiana, 46202
Viking Clinical Site #2058
Jacksonville, Florida, 32216
Viking Clinical Site #2016
Kansas City, Missouri, 64131
Viking Clinical Site #2004
Knoxville, Tennessee, 37909
Viking Clinical Site #2106
Lafayette, Louisiana, 70508
Viking Clinical Site #2014
Lake Forest, California, 92630
Viking Clinical Site #2076
Lakeland, Florida, 33803
Viking Clinical Site #2060
Lakewood Rch, Florida, 34211
Viking Clinical Site #2077
Lampasas, Texas, 76550
Viking Clinical Site #2035
Las Vegas, Nevada, 89148
Viking Clinical Site #2065
Lebanon, New Hampshire, 03756
Viking Clinical Site #2129
Lemon Grove, California, 91945
Viking Clinical Site #2069
Lexington, Kentucky, 40509
Viking Clinical Site #2040
Lexington, Kentucky, 40513
Viking Clinical Site #2051
Lincoln, California, 95648
Viking Clinical Site #2036
Little Rock, Arkansas, 72211
Viking Clinical Site #2050
Long Beach, California, 90815
Viking Clinical Site #2009
Louisville, Kentucky, 40213
Viking Clinical Site #2078
Manteca, California, 95336
Viking Clinical Site #2095
Marlton, New Jersey, 08009
Viking Clinical Site #2080
Meridian, Idaho, 83642
Viking Clinical Site #2020
Metairie, Louisiana, 70006
Viking Clinical Site #2001
Methuen, Massachusetts, 01844
Viking Clinical Site #2117
Miami, Florida, 33122
Viking Clinical Site #2087
Monroe, Louisiana, 71201
Viking Clinical Site #2053
Montclair, California, 91763
Viking Clinical Site #2110
Morehead City, North Carolina, 28557
Viking Clinical Site #2061
Morehead City, North Carolina, 28857
Viking Clinical Site #2134
Myrtle Beach, South Carolina, 29572
Viking Clinical Site #2008
Nashville, Tennessee, 37203
Viking Clinical Site #2133
New York, New York, 10036
Viking Clinical Site #2113
Norman, Oklahoma, 73069
Viking Clinical Site #2023
North Charleston, South Carolina, 29405
Viking Clinical Site #2012
Ocoee, Florida, 34761
Viking Clinical Site #2002
Ogden, Utah, 84405
Viking Clinical Site #2075
Omaha, Nebraska, 68134
Viking Clinical Site #2056
Palmetto Bay, Florida, 33157
Viking Clinical Site #2068
Panorama City, California, 91402
Viking Clinical Site #2018
Peoria, Arizona, 85381
Viking Clinical Site #2011
Port Orange, Florida, 32127
Viking Clinical Site #2097
Portland, Oregon, 97202
Viking Clinical Site #2126
Portland, Oregon, 97210
Viking Clinical Site #2034
Reno, Nevada, 89511
Viking Clinical Site #2072
Renton, Washington, 98057
Viking Clinical Site #2120
Rincon, Georgia, 31326
Viking Clinical Site #2145
Rockville, Maryland, 20850
Viking Clinical Site #2066
Rockville, Maryland, 20854
Viking Clinical Site #2132
Rolling Hills Estates, California, 90274
Viking Clinical Site #2092
Salt Lake City, Utah, 84107
Viking Clinical Site #2143
San Antonio, Texas, 78215
Viking Clinical Site #2085
San Antonio, Texas, 78222
Viking Clinical Site #2015
San Antonio, Texas, 78229
Viking Clinical Site #2131
San Diego, California, 92103
Viking Clinical Site #2039
Sandy City, Utah, 84094
Viking Clinical Site #2093
Savannah, Georgia, 31406
Viking Clinical Site #2135
Scottsdale, Arizona, 85260
Viking Clinical Site #2102
Seabrook, Texas, 77586
Viking Clinical Site #2147
Sioux City, Iowa, 68776
Viking Clinical Site #2041
Spokane, Washington, 99218
Viking Clinical Site #2052
Spring Valley, California, 91978
Viking Clinical Site #2125
Springfield, Missouri, 65807
Viking Clinical Site #2024
St. George, Utah, 84790
Viking Clinical Site #2082
Suffolk, Virginia, 23435
Viking Clinical Site #2019
Tucson, Arizona, 85711
Viking Clinical Site #2137
Tulsa, Oklahoma, 74133
Viking Clinical Site #2109
Tustin, California, 92780
Viking Clinical Site #2127
Valparaiso, Indiana, 46383
Viking Clinical Site #2067
Van Nuys, California, 91405
Viking Clinical Site #2079
Walnut Creek, California, 94598
Viking Clinical Site #2022
West Des Moines, Iowa, 50266
Viking Clinical Site #2057
West Palm Beach, Florida, 33407
Viking Clinical Site #2032
Westfield, New York, 14787
Viking Clinical Site #2099
Wichita, Kansas, 67207
Viking Clinical Site #2115
Winston-Salem, North Carolina, 27157
Viking Clinical Site #2025
Woodstock, Georgia, 30189
Viking Clinical Site #2038
Ypsilanti, Michigan, 48197
Puerto Rico2 sites
Viking Clinical Site #2130
Mayagüez, 00680
Viking Clinical Site #2086
San Juan, 00927
About this study
Official title: 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
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
- Conditions
- Weight Loss
- Being tested
- VK2735
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK2735Drug
VK2735 is a peptide GLP-1 and GIP dual agonist administered Once Weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo Assignment | Placebo comparator | VK2735 Placebo Comparator Once Weekly Receives: Drug: VK2735 |
| Active Assignment (Dose #1) | Experimental | VK2735 7.5mg Once Weekly Receives: Drug: VK2735 |
| Active Assignment (Dose #2) | Experimental | VK2735 12.5mg Once Weekly Receives: Drug: VK2735 |
| Active Assignment (Dose #3) | Experimental | VK2735 17.5mg Once Weekly Receives: Drug: VK2735 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline to Week 78 in body weight
Measured: 78 Weeks
Secondary outcomes (1)
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment
Measured: 78 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start23 Jun 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,100 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
- NCT07104383
- Sponsor's protocol ID
- VK2735-302
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07104383
- Acronym / sponsor ID
- VK2735-302
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 5 Aug 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Assignment | Placebo comparator | Drug: VK2735VK2735 Placebo Comparator Once Weekly |
| Active Assignment (Dose #1) | Experimental | Drug: VK2735VK2735 7.5mg Once Weekly |
| Active Assignment (Dose #2) | Experimental | Drug: VK2735VK2735 12.5mg Once Weekly |
| Active Assignment (Dose #3) | Experimental | Drug: VK2735VK2735 17.5mg Once Weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 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
Key exclusion criteria (12 listed)
- 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 (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)
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 administered Once Weekly | Drug | Active Assignment (Dose #1), Active Assignment (Dose #2), Active Assignment (Dose #3), Placebo Assignment |
Primary outcome
Percent change in body weight from baseline to Week 78 in body weight
Time frame: 78 Weeks
1 secondary outcome
Percentage of participants who achieve ≥5%, ≥10%, ≥15% and ≥20% body weight reduction after 78 weeks of treatment
Time frame: 78 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
127 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VK2735 in people with Weight Loss, run by Viking Therapeutics, Inc. at 127 sites in 2 countries.
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 3 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 127 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 change in body weight from baseline to Week 78 in body weight (time frame: 78 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 7 Apr 2026.