ObesityPhase 2EVOLVE-2NCT07281937
A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
A Phase 2 study testing VRB-101 in people with Obesity and Overweight, run by Verdiva Bio Dev Limited at 22 sites in United States.
Trial summary
The aim of this study is to evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in participants who have obesity or overweight with weight-related comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- VRB-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 22 sitesUnited States
- Study dates
- 25 Nov 2025to 23 Jul 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have hemoglobin A1c (HbA1c) <6.5%.
- Have a BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity.
- Have a self-reported history of stable body weight for the 3 months prior to randomization (≤5% body weight change).
- Participants of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
Who cannot join
- Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or other forms of diabetes mellitus. A participant with a history of gestational diabetes may be included in the study if the participant has an HbA1c < 6.5% at Screening.
- Have at least 1 laboratory value suggestive of diabetes during Screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol) or random glucose ≥200 mg/dL (11.1 mmol/L).
- Have had exposure to glucagon-like peptide -1 (GLP-1) 6 months prior to Screening or any prior history of known or suspected hypersensitivity/allergies, intolerability, or lack of efficacy to these medications. Have known or suspected hypersensitivity to study intervention(s), to selective GLP-1 receptor agonist (RA) or glucose-dependent insulinotropic peptide (GIP)/GLP-1 or GLP-1/glucagon (GCG) dual receptor agonists.
- Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time within the dosing period, including follow -up, and for at least 60 days after the last dose of study intervention.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Clinical Study Site 111
Anaheim, California, 92801
Clinical Study Site 103
Anniston, Alabama, 36207
Clinical Study Site 117
Binghamton, New York, 13905
Clinical Study Site 120
Charlotte, North Carolina, 28210
Clinical Study Site 109
Cullman, Alabama, 35055
Clinical Study Site 112
Dallas, Texas, 75251
Clinical Study Site 119
Decatur, Georgia, 30030
Clinical Study Site 114
Duncansville, Pennsylvania, 16635
Clinical Study Site 115
Knoxville, Tennessee, 37909
Clinical Study Site 113
Little Rock, Arkansas, 72205
Clinical Study Site 108
Monroe, North Carolina, 28112
Clinical Study Site 107
Montclair, California, 91763
Clinical Study Site 105
Norman, Oklahoma, 73069
Clinical Study Site 121
Omaha, Nebraska, 68134
Clinical Study Site 110
Phoenix, Arizona, 85028
Clinical Study Site 101
Rochester, New York, 14609
Clinical Study Site 102
San Antonio, Texas, 78229
Clinical Study Site 104
San Antonio, Texas, 78240
Clinical Study Site 122
Southfield, Michigan, 48076
Clinical Study Site 118
Tarzana, California, 91356
Clinical Study Site 116
West Des Moines, Iowa, 50266
Clinical Study Site 106
Wichita, Kansas, 67207
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
The aim of this study is to evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in participants who have obesity or overweight with weight-related comorbidities.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study of oral ecnoglutide (VRB-101), with 5 active arms and 1 placebo arm. The study will include a Screening Period of 4 weeks, followed by a 20-week Study Treatment Period and a 4-week Safety Follow-up Period prior to the end of study (EOS) visit.
- Conditions
- Obesity, Overweight
- Being tested
- VRB-101, Placebo
- Keywords
- Hypertension, Weight reduction, Dose Escalation, Glucagon-like peptide-1 (GLP-1)
- Medical subject headings
- Obesity, Overweight, Hypertension, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRB-101Drug
Also called Oral Ecnoglutide
VRB-101 tablets will be administered orally.
PlaceboDrug
Placebo tablets will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Schedule A: VRB-101 (Active Arm 1) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| Schedule A: VRB-101 (Active Arm 2) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| Schedule A: VRB-101 (Active Arm 3) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| Schedule B: VRB-101 (Active Arm 4) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| Schedule B: VRB-101 (Active Arm 5) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| Pooled Placebo | Placebo comparator | Participants will receive matching placebo to VRB-101 once every week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in body weight
To evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in Schedule A dose regimens.
Measured: From Baseline (Day 0) up to Week 21
Secondary outcomes (6)
Absolute change from baseline in body weight
To compare the effect of VRB-101 versus placebo on body weight in Schedule A.
Measured: From Baseline (Day 0) up to Week 21
Percentage of participants who achieve 5% or more body weight reduction
To compare the effect of VRB-101 versus placebo on body weight in Schedule A
Measured: From Baseline (Day 0) up to Week 21
Change from baseline in body mass index (BMI)
To compare the effect of VRB-101 versus placebo on body weight in Schedule A.
Measured: From Baseline (Day 0) up to Week 21
Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
To assess safety and tolerability of study interventions. Adverse events (AEs) reported after first administration of study intervention will be designated as a TEAE.
Measured: From Baseline (Day 0) up to Week 24
Change from baseline in blood pressure (BP)
To assess safety and tolerability of study interventions.
Measured: From Baseline (Day 0) up to Week 24
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS systematically assesses suicidal ideation and behavior using yes/no questions, ordinal severity ratings (0-5), and intensity subscales. Results at End of Study will be compared to Baseline.
Measured: From Baseline (Day 0) up to Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start25 Nov 2025
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verdiva Bio Dev Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281937
- Sponsor's protocol ID
- VRB-101-201
- Acronym
- EVOLVE-2
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
- ClinicalTrials.gov ID
- NCT07281937
- Acronym / sponsor ID
- EVOLVE-2 / VRB-101-201
- Conditions
- Obesity, Overweight
- Keywords
- Hypertension, Weight reduction, Dose Escalation, Glucagon-like peptide-1 (GLP-1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Verdiva Bio Dev LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 15 Dec 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.
The aim of this study is to evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in participants who have obesity or overweight with weight-related comorbidities.
Detailed description
This is a randomized, double-blind, placebo-controlled study of oral ecnoglutide (VRB-101), with 5 active arms and 1 placebo arm. The study will include a Screening Period of 4 weeks, followed by a 20-week Study Treatment Period and a 4-week Safety Follow-up Period prior to the end of study (EOS) visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Schedule A: VRB-101 (Active Arm 1) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| Schedule A: VRB-101 (Active Arm 2) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| Schedule A: VRB-101 (Active Arm 3) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| Schedule B: VRB-101 (Active Arm 4) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| Schedule B: VRB-101 (Active Arm 5) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| Pooled Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to VRB-101 once every week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have hemoglobin A1c (HbA1c) <6.5%.
- Have a BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity.
- Have a self-reported history of stable body weight for the 3 months prior to randomization (≤5% body weight change).
- Participants of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
Key exclusion criteria (4 listed)
- Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or other forms of diabetes mellitus. A participant with a history of gestational diabetes may be included in the study if the participant has an HbA1c < 6.5% at Screening.
- Have at least 1 laboratory value suggestive of diabetes during Screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol) or random glucose ≥200 mg/dL (11.1 mmol/L).
- Have had exposure to glucagon-like peptide -1 (GLP-1) 6 months prior to Screening or any prior history of known or suspected hypersensitivity/allergies, intolerability, or lack of efficacy to these medications. Have known or suspected hypersensitivity to study intervention(s), to selective GLP-1 receptor agonist (RA) or glucose-dependent insulinotropic peptide (GIP)/GLP-1 or GLP-1/glucagon (GCG) dual receptor agonists.
- Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time within the dosing period, including follow -up, and for at least 60 days after the last dose of study intervention.
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 |
|---|---|---|
| VRB-101Also: Oral EcnoglutideVRB-101 tablets will be administered orally. | Drug | Schedule A: VRB-101 (Active Arm 1), Schedule A: VRB-101 (Active Arm 2), Schedule A: VRB-101 (Active Arm 3), Schedule B: VRB-101 (Active Arm 4), Schedule B: VRB-101 (Active Arm 5) |
| PlaceboPlacebo tablets will be administered orally. | Drug | Pooled Placebo |
Primary outcome
Mean percent change from baseline in body weight
Time frame: From Baseline (Day 0) up to Week 21
To evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in Schedule A dose regimens.
6 secondary outcomes
Absolute change from baseline in body weight
Time frame: From Baseline (Day 0) up to Week 21
Percentage of participants who achieve 5% or more body weight reduction
Time frame: From Baseline (Day 0) up to Week 21
Change from baseline in body mass index (BMI)
Time frame: From Baseline (Day 0) up to Week 21
Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: From Baseline (Day 0) up to Week 24
Change from baseline in blood pressure (BP)
Time frame: From Baseline (Day 0) up to Week 24
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline (Day 0) up to Week 21
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 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
22 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 VRB-101 in people with Obesity and Overweight, run by Verdiva Bio Dev Limited at 22 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 4 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Mean percent change from baseline in body weight (time frame: From Baseline (Day 0) up to Week 21). 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 17 Aug 2026.