Weight LossPhase 3VANQUISH 1NCT07104500
VK2735 for Weight Management Phase 3
A Phase 3 study testing VK2735 in people with Weight Loss, run by Viking Therapeutics, Inc. at 137 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 who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or… 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
- 4,500 participants
- Where
- 137 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) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated)
- Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease
- Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure
- BMI calculated at the Screening visit will be used to determine eligibility
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 (excluding 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, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
- Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
- Treatment with glucose-lowering agent(s) within 90 days before screening
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- History of acute or chronic pancreatitis
Trial locations and contacts
137 sites in 2 countries.
137 sites in 2 countries
United States135 sites
Viking Clinical Site #1047
Abilene, Texas, 79606
Viking Clinical Site #1088
Albany, New York, 12205
Viking Clinical Site #1029
Albuquerque, New Mexico, 87109
Viking Clinical Site #1098
Arlington, Virginia, 22205
Viking Clinical Site #1116
Atlanta, Georgia, 30329
Viking Clinical Site #1063
Austin, Texas, 78131
Viking Clinical Site #1007
Austin, Texas, 78705
Viking Clinical Site #1118
Baton Rouge, Louisiana, 70808
Viking Clinical Site #1139
Baton Rouge, Louisiana, 70809
Viking Clinical Site #1091
Bellaire, Texas, 77401
Viking Clinical Site #1037
Birmingham, Alabama, 35235
Viking Clinical Site #1064
Birmingham, Alabama, 35249
Viking Clinical Site #1103
Boston, Massachusetts, 02114
Viking Clinical Site #1124
Brownsville, Texas, 78526
Viking Clinical Site #1010
Butte, Montana, 59701
Viking Clinical Site #1005
Chandler, Arizona, 85210
Viking Clinical Site #1141
Charlotte, North Carolina, 28250
Viking Clinical Site #1094
Chevy Chase, Maryland, 20815
Viking Clinical Site #1006
Chicago, Illinois, 60607
Viking Clinical Site #1090
Chicago, Illinois, 60640
Viking Clinical Site #1071
Chula Vista, California, 91911
Viking Clinical Site #1043
Cincinnati, Ohio, 45219
Viking Clinical Site #1074
Cincinnati, Ohio, 45242
Viking Clinical Site #1031
City of Saint Peters, Missouri, 63303
Viking Clinical Site #1013
Clearwater, Florida, 33756
Viking Clinical Site #1121
Clearwater, Florida, 33761
Viking Clinical Site #1044
Cleveland, Ohio, 44122
Viking Clinical Site #1030
Columbus, Georgia, 31904
Viking Clinical Site #1089
Columbus, Ohio, 43215
Viking Clinical Site #1003
Cooper City, Florida, 33024
Viking Clinical Site #1049
Dallas, Texas, 75230
Viking Clinical Site #1048
Dallas, Texas, 75235
Viking Clinical Site #1112
DeLand, Florida, 32720
Viking Clinical Site #1107
Delray Beach, Florida, 33445
Viking Clinical Site #1119
Denver, Colorado, 80210
Viking Clinical Site #1122
Durham, North Carolina, 27701
Viking Clinical Site #1045
East Greenwich, Rhode Island, 02818
Viking Clinical Site #1042
East Syracuse, New York, 13057
Viking Clinical Site #1070
Escondido, California, 92025
Viking Clinical Site #1027
Fargo, North Dakota, 58104
Viking Clinical Site #1144
Fayetteville, North Carolina, 28304
Viking Clinical Site #1017
Flagstaff, Arizona, 86001
Viking Clinical Site #1083
Fort Myers, Florida, 33912
Viking Clinical Site #1111
Frisco, Texas, 75033
Viking Clinical Site #1026
Greensboro, North Carolina, 27410
Viking Clinical Site #1028
Greenville, South Carolina, 29607
Viking Clinical Site #1140
Gulfport, Mississippi, 39503
Viking Clinical Site #1096
Hartsdale, New York, 10530
Viking Clinical Site #1062
Honolulu, Hawaii, 96814
Viking Clinical Site #1046
Houston, Texas, 77040
Viking Clinical Site #1054
Huntington Park, California, 90255
Viking Clinical Site #1128
Huntsville, Alabama, 35801
Viking Clinical Site #1058
Jacksonville, Florida, 32216
Viking Clinical Site #1016
Kansas City, Missouri, 64131
Viking Clinical Site #1004
Knoxville, Tennessee, 37909
Viking Clinical Site #1106
Lafayette, Louisiana, 70508
Viking Clinical Site #1014
Lake Forest, California, 92630
Viking Clinical Site #1076
Lakeland, Florida, 33803
Viking Clinical Site #1060
Lakewood Rch, Florida, 34211
Viking Clinical Site #1077
Lampasas, Texas, 76550
Viking Clinical Site #1035
Las Vegas, Nevada, 89148
Viking Clinical Site #1065
Lebanon, New Hampshire, 03756
Viking Clinical Site #1129
Lemon Grove, California, 91945
Viking Clinical Site #1069
Lexington, Kentucky, 40509
Viking Clinical Site #1040
Lexington, Kentucky, 40513
Viking Clinical Site #1051
Lincoln, California, 95648
Viking Clinical Site #1036
Little Rock, Arkansas, 72211
Viking Clinical Site #1050
Long Beach, California, 90815
Viking Clinical Site #1055
Los Angeles, California, 90057
Viking Clinical Site #1009
Louisville, Kentucky, 40213
Viking Clinical Site #1078
Manteca, California, 95336
Viking Clinical Site #1095
Marlton, New Jersey, 08009
Viking Clinical Site #1102
Medford, Oregon, 97504
Viking Clinical Site #1080
Meridian, Idaho, 83642
Viking Clinical Site #1020
Metairie, Louisiana, 70006
Viking Clinical Site #1001
Methuen, Massachusetts, 01844
Viking Clinical Site #1117
Miami, Florida, 33122
Viking Clinical Site #1081
Mobile, Alabama, 36608
Viking Clinical Site #1087
Monroe, Louisiana, 71201
Viking Clinical Site #1053
Montclair, California, 91763
Viking Clinical Site #1110
Morehead City, North Carolina, 28557
Viking Clinical Site #1061
Morehead City, North Carolina, 28857
Viking Clinical Site #1134
Myrtle Beach, South Carolina, 29572
Viking Clinical Site #1008
Nashville, Tennessee, 37203
Viking Clinical Site #1136
Needham, Massachusetts, 02492
Viking Clinical Site #1059
New Port Richey, Florida, 34652
Viking Clinical Site #1133
New York, New York, 10036
Viking Clinical Site #1142
New York, New York, 10065
Viking Clinical Site #1113
Norman, Oklahoma, 73069
Viking Clinical Site #1023
North Charleston, South Carolina, 29405
Viking Clinical Site #1012
Ocoee, Florida, 34761
Viking Clinical Site #1002
Ogden, Utah, 84405
Viking Clinical Site #1075
Omaha, Nebraska, 68134
Viking Clinical Site #1056
Palmetto Bay, Florida, 33157
Viking Clinical Site #1068
Panorama City, California, 91402
Viking Clinical Site #1018
Peoria, Arizona, 85381
Viking Clinical Site #1011
Port Orange, Florida, 32127
Viking Clinical Site #1097
Portland, Oregon, 97202
Viking Clinical Site #1126
Portland, Oregon, 97210
Viking Clinical Site #1034
Reno, Nevada, 89511
Viking Clinical Site #1072
Renton, Washington, 98057
Viking Clinical Site #1120
Rincon, Georgia, 31326
Viking Clinical Site #1066
Rockville, Maryland, 20854
Viking Clinical Site #1132
Rolling Hills Estates, California, 90274
Viking Clinical Site #1092
Salt Lake City, Utah, 84107
Viking Clinical Site #1143
San Antonio, Texas, 78215
Viking Clinical Site #1085
San Antonio, Texas, 78222
Viking Clinical Site #1073
San Antonio, Texas, 78229
Viking Clinical Site #1131
San Diego, California, 92103
Viking Clinical Site #1039
Sandy City, Utah, 84094
Viking Clinical Site #1104
Santa Maria, California, 93458
Viking Clinical Site #1093
Savannah, Georgia, 31406
Viking Clinical Site #1135
Scottsdale, Arizona, 85260
Viking Clinical Site #1041
Spokane, Washington, 99218
Viking Clinical Site #1052
Spring Valley, California, 91978
Viking Clinical Site #1125
Springfield, Missouri, 65807
Viking Clinical Site #1108
St Louis, Missouri, 63108
Viking Clinical Site #1024
St. George, Utah, 84790
Viking Clinical Site #1082
Suffolk, Virginia, 23435
Viking Clinical Site #1021
The Bronx, New York, 10455
Viking Clinical Site #1019
Tucson, Arizona, 85711
Viking Clinical Site #1137
Tulsa, Oklahoma, 74133
Viking Clinical Site #1109
Tustin, California, 92780
Viking Clinical Site #1127
Valparaiso, Indiana, 46383
Viking Clinical Site #1067
Van Nuys, California, 91405
Viking Clinical Site #1101
Waco, Texas, 76710
Viking Clinical Site #1079
Walnut Creek, California, 94598
Viking Clinical Site #1123
Washington D.C., District of Columbia, 20036
Viking Clinical Site #1022
West Des Moines, Iowa, 50266
Viking Clinical Site #1057
West Palm Beach, Florida, 33407
Viking Clinical Site #1032
Westfield, New York, 14787
Viking Clinical Site #1138
Westmont, Illinois, 60559
Viking Clinical Site #1099
Wichita, Kansas, 67207
Viking Clinical Site #1025
Woodstock, Georgia, 30189
Viking Clinical Site #1038
Ypsilanti, Michigan, 48197
Puerto Rico2 sites
Viking Clinical Site #1130
Mayagüez, 00680
Viking Clinical Site #1086
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 Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
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 who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
- 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.
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
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
- 4,500 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
- NCT07104500
- Sponsor's protocol ID
- VK2735-301
- Acronym
- VANQUISH 1
- Status last verified
- Nov 2025
- First submitted
- 29 Jul 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. 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 Without Type 2 Diabetes Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition
- ClinicalTrials.gov ID
- NCT07104500
- Acronym / sponsor ID
- VANQUISH 1 / VK2735-301
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,500 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 who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.
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 (5 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)
Key exclusion criteria (8 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 (excluding 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, mucosa ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)
- Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes)
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
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment
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 24 Nov 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.
137 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 137 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 5 inclusion and 8 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 137 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?
Percentage change in body weight from baseline for participants receiving VK2735 after 78 weeks of treatment (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 24 Nov 2025.