Obesity and Cardiovascular RiskPhase 2QUELL-CVNCT07656727
A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
A Phase 2 study testing Oral BGE-102 in people with Obesity and Cardiovascular Risk, run by BioAge Labs, Inc. at 17 sites in 2 countries.
Trial summary
The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Cardiovascular Risk
- What is being tested?
- Oral BGE-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 11 Jun 2026to Dec 2026
- Phase
- Phase 2
- 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
- Obese Male and Female adults with BMI 32-42 kg/m²
- Elevated blood test for hsCRP consistent with chronic systemic inflammation
- At least one cardiovascular risk factor or metabolic syndrome feature
- Stable background therapies and willing to maintain stable diet/exercise habits during the study
Who cannot join
- Type 1 diabetes,
- Uncontrolled Type 2 diabetes,
- Uncontrolled hypertension and /or hyperlipidemia
- Recent weight change of 5% or more,
- Use of weight-loss medications/programs
- Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
Show all 11Show fewer
- Clinically significant ECG abnormalities or arrhythmias
- Use of prohibited medications (including GLP-1 therapies, immunosuppressants, chronic anti-inflammatory drugs, or moderate or strong CYP3A4 modulators)
- Contraindications to MRI
- Clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass [bariatric] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity
- Women who are pregnant or nursing
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States16 sites
Site 112
Austin, Texas, 78759
Site 108
Chandler, Arizona, 85225
Site 114
Dallas, Texas, 75230
Site 111
Hartsdale, New York, 10530
Site 113
Kansas City, Missouri, 64131
Site 116
Las Vegas, Nevada, 89109
Site 103
Lexington, Kentucky, 40509
Site 109
Maitland, Florida, 32751
Site 102
Miami, Florida, 33172
Site 115
Peoria, Arizona, 85381
Site 104
Port Orange, Florida, 32127
Site 106
Rockville, Maryland, 20854
Site 100
Rogers, Arkansas, 72758
Site 101
San Antonio, Texas, 78240
Site 117
Sugar Land, Texas, 77478
Site 110
Tucson, Arizona, 85711
About this study
Official title: A Phase 2, Randomized, Double-Blind, Dose-Range, Placebo-Controlled, 12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.
Read the detailed description
The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment.
Study details include:
- The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).
- The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.
- The treatment duration will be up to 12 weeks. BGE-102 will be given as Dose A, Dose B or Dose C QD capsules or placebo QD capsules for the entire 12-week treatment period.
- Conditions
- Obesity and Cardiovascular Risk
- Being tested
- Oral BGE-102, Oral Placebo Matching BGE-102
- Keywords
- Obesity, Cardiovascular, BGE-102, hsCRP, BioAge, NLRP3
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral BGE-102Drug
Capsules
Oral Placebo Matching BGE-102Drug
Capsules
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BGE-102 Dose A | Experimental | capsules dosed once daily in the morning Receives: Drug: Oral BGE-102 |
| Arm B: BGE-102 Dose B | Experimental | capsules dosed once daily in the morning Receives: Drug: Oral BGE-102 |
| Arm C: BGE-102 Dose C | Experimental | capsules dosed once daily in the morning Receives: Drug: Oral BGE-102 |
| Arm D: Dose D | Placebo comparator | capsules dosed once daily in the morning Receives: Drug: Oral Placebo Matching BGE-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in hsCRP (Dose A)
Percent change in hsCRP of the BGE-102 Dose A daily compared to Placebo
Measured: Week 12
Percent change in hsCRP (Dose B)
Percent change in hsCRP of the BGE-102 Dose B daily compared to Placebo
Measured: Week 12
Percent change in hsCRP (Dose C)
Percent change in hsCRP of the BGE-102 Dose C daily compared to Placebo
Measured: Week 12
Secondary outcomes (2)
Incidence of serious adverse events (SAEs)
Measured: Up to Week 16
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start11 Jun 2026
- Primary completion30 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Cardiovascular RiskStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAge Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656727
- Sponsor's protocol ID
- BGE-102-005
- Acronym
- QUELL-CV
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Dose-Range, Placebo-Controlled, 12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT07656727
- Acronym / sponsor ID
- QUELL-CV / BGE-102-005
- Conditions
- Obesity and Cardiovascular Risk
- Keywords
- Obesity, Cardiovascular, BGE-102, hsCRP, BioAge, NLRP3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- BioAge Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jun 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 learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.
Detailed description
The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment.
Study details include:
- The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks).
- The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16.
- The treatment duration will be up to 12 weeks. BGE-102 will be given as Dose A, Dose B or Dose C QD capsules or placebo QD capsules for the entire 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: BGE-102 Dose A | Experimental | Drug: Oral BGE-102capsules dosed once daily in the morning |
| Arm B: BGE-102 Dose B | Experimental | Drug: Oral BGE-102capsules dosed once daily in the morning |
| Arm C: BGE-102 Dose C | Experimental | Drug: Oral BGE-102capsules dosed once daily in the morning |
| Arm D: Dose D | Placebo comparator | Drug: Oral Placebo Matching BGE-102capsules dosed once daily in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obese Male and Female adults with BMI 32-42 kg/m²
- Elevated blood test for hsCRP consistent with chronic systemic inflammation
- At least one cardiovascular risk factor or metabolic syndrome feature
- Stable background therapies and willing to maintain stable diet/exercise habits during the study
Key exclusion criteria (11 listed)
- Type 1 diabetes,
- Uncontrolled Type 2 diabetes,
- Uncontrolled hypertension and /or hyperlipidemia
- Recent weight change of 5% or more,
- Use of weight-loss medications/programs
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 |
|---|---|---|
| Oral BGE-102Capsules | Drug | Arm A: BGE-102 Dose A, Arm B: BGE-102 Dose B, Arm C: BGE-102 Dose C |
| Oral Placebo Matching BGE-102Capsules | Drug | Arm D: Dose D |
Primary outcome
Percent change in hsCRP (Dose A)
Time frame: Week 12
Percent change in hsCRP of the BGE-102 Dose A daily compared to Placebo
Percent change in hsCRP (Dose B)
Time frame: Week 12
Percent change in hsCRP of the BGE-102 Dose B daily compared to Placebo
Percent change in hsCRP (Dose C)
Time frame: Week 12
Percent change in hsCRP of the BGE-102 Dose C daily compared to Placebo
2 secondary outcomes
Incidence of serious adverse events (SAEs)
Time frame: Up to Week 16
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 16
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 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity and Cardiovascular Risk
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Enrolling by invitationObservational study
Białystok PLUS - Polish Longitudinal University Study
Cardiovascular Diseases, Diabetes
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.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral BGE-102 in people with Obesity and Cardiovascular Risk, run by BioAge Labs, Inc. at 17 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 4 inclusion and 11 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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?
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 hsCRP (Dose A) (time frame: Week 12). The study lists 3 primary outcomes in all. 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 10 Sep 2026.