ObesityPhase 2NCT07553299
A Study of Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance 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 20 sites in United States.
Trial summary
The purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of 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, Weight Maintenance
- 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
- 8 participants
- Where
- 20 sitesUnited States
- Study dates
- 12 Jun 2026to 11 Sep 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 a history of BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity at the time of initiation of subcutaneous (SC) semaglutide and/or tirzepatide treatment.
- Documented history of having obesity or overweight with weight-related comorbidities per medical records at the time of initiation of SC semaglutide and/or tirzepatide treatment.
- History of treatment with weekly SC semaglutide and/or tirzepatide for a minimum of 6 months prior to Screening.
- Documented weight reduction of ≥10% in 6 months and no clinically relevant weight regain.
- Participants of childbearing potential (POCBP) must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
Who cannot join
- Current or past diagnosis of diabetes mellitus [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 HbA1c <6.5% at Screening and is not on medication to lower glucose.
- 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).
- Diagnosed with obesity due to endocrinologic disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- History of clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction).
- Evidence of uncontrolled hypothyroidism or hyperthyroidism based on an abnormal thyroid-stimulating hormone (TSH).
- Personal or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
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- Evidence of a significant, uncontrolled endocrine abnormality (for example, thyrotoxicosis or adrenal crises)
- Renal impairment measured as eGFR <30 mL/min/1.73 m2
- History of acute or chronic pancreatitis or clinically significant gallbladder disease.
- Triglycerides >500 mg/dL (5.7 mmol/L) at Screening.
- Poorly controlled hypertension or an elevated resting pulse rate (>100 bpm).
- Current treatment with or history of treatment with (within 3 months prior to Screening) medications that may cause significant weight gain.
- Prior or planned surgical treatment for obesity, plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening.
- Known hypersensitivity to any of the study drug ingredients.
- Are pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study and for at least 60 days after completion of the study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Clinical Study Site 204
Bradenton, Florida, 34209
Clinical Study Site 205
Buffalo, New York, 14217
Clinical Study Site 202
Cullman, Alabama, 35055
Clinical Study Site 213
El Dorado, Kansas, 67042
Clinical Study Site 217
Houston, Texas, 77008
Clinical Study Site 211
Houston, Texas, 77040
Clinical Study Site 218
Irving, Texas, 75063
Clinical Study Site 209
Jackson, Tennessee, 38305
Clinical Study Site 206
Lenoir, North Carolina, 28645
Clinical Study Site 201
Little Rock, Arkansas, 72205
Clinical Study Site 219
Niles, Illinois, 60714
Clinical Study Site 220
Oklahoma City, Oklahoma, 73111
Clinical Study Site 221
Orange City, Florida, 32763
Clinical Study Site 210
Petal, Mississippi, 39465
Clinical Study Site 203
Phoenix, Arizona, 85028
Clinical Study Site 207
Richmond, Virginia, 23226
Clinical Study Site 214
Santa Maria, California, 93454
Clinical Study Site 215
St. Petersburg, Florida, 33704
Clinical Study Site 216
Stamford, Connecticut, 06905
Clinical Study Site 212
Tempe, Arizona, 85281
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Identify the Optimal Weekly Oral Dose of Ecnoglutide (VRB-101) for Maintaining Body Weight in Participants With Obesity or Overweight Who Have Weight-Related Comorbidities
The purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of obesity or overweight with weight-related comorbidities.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral ecnoglutide (VRB-101) in participants with a history of obesity or overweight who have achieved weight reduction after 6 months of treatment with injectable semaglutide or tirzepatide. The study comprises three active arms and one placebo arm.
The study will include a Screening Period of approximately 4 weeks, followed by a 16-week Treatment Period and a 4-week Safety Follow-up Period prior to the end of the study.
- Conditions
- Obesity, Overweight, Weight Maintenance
- Being tested
- VRB-101, Placebo
- Keywords
- Weight reduction, Glucagon-like peptide-1 (GLP-1), Chronic Weight Management
- Medical subject headings
- Obesity, Overweight, 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 |
|---|---|---|
| VRB-101 (Active Arm 1) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| VRB-101 (Active Arm 2) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| VRB-101 (Active Arm 3) | Experimental | Participants will receive VRB-101 once every week. Receives: Drug: VRB-101 |
| 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.
To identify the dose of VRB-101 for weight maintenance
Measured: Baseline to End of Treatment (Week 17)
Secondary outcomes (5)
Percent change in body weight from baseline
Measured: Baseline to End of Treatment (Week 17)
Absolute change in body weight from baseline
Measured: Baseline to End of Treatment (Week 17)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Measured: Baseline to Week 24
Change in blood pressure from baseline
Measured: Baseline to End of Treatment (Week 17)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline
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: Baseline to End of Treatment (Week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start12 Jun 2026
- Primary completion11 Sep 2026
- Study completion11 Sep 2026
Why it stopped: The Study Sponsor made a business decision not to continue the study. The decision was not based on safety findings.
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
- 8 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
- NCT07553299
- Sponsor's protocol ID
- VRB-101-202
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Identify the Optimal Weekly Oral Dose of Ecnoglutide (VRB-101) for Maintaining Body Weight in Participants With Obesity or Overweight Who Have Weight-Related Comorbidities
- ClinicalTrials.gov ID
- NCT07553299
- Acronym / sponsor ID
- VRB-101-202
- Conditions
- Obesity, Overweight, Weight Maintenance
- Keywords
- Weight reduction, Glucagon-like peptide-1 (GLP-1), Chronic Weight Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Study Sponsor made a business decision not to continue the study. The decision was not based on safety findings.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Verdiva Bio Dev LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 11 Sep 2026 (actual)
- Study completion
- 11 Sep 2026 (actual)
- First posted
- 28 Apr 2026 (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 purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of obesity or overweight with weight-related comorbidities.
Detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral ecnoglutide (VRB-101) in participants with a history of obesity or overweight who have achieved weight reduction after 6 months of treatment with injectable semaglutide or tirzepatide. The study comprises three active arms and one placebo arm.
The study will include a Screening Period of approximately 4 weeks, followed by a 16-week Treatment Period and a 4-week Safety Follow-up Period prior to the end of the study.
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 |
|---|---|---|
| VRB-101 (Active Arm 1) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| VRB-101 (Active Arm 2) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| VRB-101 (Active Arm 3) | Experimental | Drug: VRB-101Participants will receive VRB-101 once every week. |
| 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 (5 listed)
- Have a history of BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity at the time of initiation of subcutaneous (SC) semaglutide and/or tirzepatide treatment.
- Documented history of having obesity or overweight with weight-related comorbidities per medical records at the time of initiation of SC semaglutide and/or tirzepatide treatment.
- History of treatment with weekly SC semaglutide and/or tirzepatide for a minimum of 6 months prior to Screening.
- Documented weight reduction of ≥10% in 6 months and no clinically relevant weight regain.
- Participants of childbearing potential (POCBP) must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
Key exclusion criteria (15 listed)
- Current or past diagnosis of diabetes mellitus [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 HbA1c <6.5% at Screening and is not on medication to lower glucose.
- 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).
- Diagnosed with obesity due to endocrinologic disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- History of clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction).
- Evidence of uncontrolled hypothyroidism or hyperthyroidism based on an abnormal thyroid-stimulating hormone (TSH).
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 | VRB-101 (Active Arm 1), VRB-101 (Active Arm 2), VRB-101 (Active Arm 3) |
| PlaceboPlacebo tablets will be administered orally. | Drug | Placebo |
Primary outcome
To identify the dose of VRB-101 for weight maintenance
Time frame: Baseline to End of Treatment (Week 17)
5 secondary outcomes
Percent change in body weight from baseline
Time frame: Baseline to End of Treatment (Week 17)
Absolute change in body weight from baseline
Time frame: Baseline to End of Treatment (Week 17)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Time frame: Baseline to Week 24
Change in blood pressure from baseline
Time frame: Baseline to End of Treatment (Week 17)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline
Time frame: Baseline to End of Treatment (Week 17)
Results and safety
The study was stopped early (reason given: The Study Sponsor made a business decision not to continue the study. The decision was not based on safety findings.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 VRB-101 in people with Obesity and Overweight, run by Verdiva Bio Dev Limited 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 13 Oct 2026. 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 was stopped early (reason given: The Study Sponsor made a business decision not to continue the study. The decision was not based on safety findings.). Results are not available in the source record.
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?
To identify the dose of VRB-101 for weight maintenance (time frame: Baseline to End of Treatment (Week 17)). 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 13 Oct 2026.