ObesityPhase 2NCT06277934
A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities
A Phase 2 study testing RGT001-075 in people with Obesity, run by Regor Pharmaceuticals Inc. at 10 sites in United States.
Trial summary
The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- RGT001-075
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Mar 2024to 13 Aug 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years
- Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
- Have had a stable body weight for the 3 months prior to randomization
Who cannot join
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
- Have a prior or planned surgical treatment for obesity
- Have or plan to have endoscopic and/or device-based therapy for obesity
- Have any prior diagnosis of diabetes
- Have an electrocardiogram (ECG) with abnormalities
- Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
- Have a history of suicide attempt.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Velocity Clinical Research
Cleveland, Ohio, 44122
Velocity Clinical Research
Dallas, Texas, 75230
Velocity Clinical Research
Durham, North Carolina, 27701
Velocity Clinical Research
East Greenwich, Rhode Island, 02818
Velocity Clinical Research
Los Angeles, California, 90057
Velocity Clinical Research
Medford, Oregon, 97504
Velocity Clinical Research
Omaha, Nebraska, 68134
Velocity Clinical Research
Valparaiso, Indiana, 46383
Velocity Clinical Research
Vestal, New York, 13850
Velocity Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities
The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity
- Conditions
- Obesity
- Being tested
- RGT001-075, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGT001-075Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| RGT001-075 Group | Experimental | Patients will receive once daily dose of study drug for a total of 12 weeks Receives: Drug: RGT001-075 |
| Placebo Group | Placebo comparator | Patients will receive once daily dose of matching placebo for a total of 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings
Measured: 14 weeks
Secondary outcomes (10)
Percent change in body weight
Percent change in body weight from baseline at Week 12
Measured: 12 weeks
Change in body weight in kilogram
Change in body weight from baseline at Week 12
Measured: 12 weeks
Percentage of participants who achieve ≥5% and ≥10% body weight reduction
Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12
Measured: 12 weeks
Change in Body mass index (BMI) in kg/m^2
Change in BMI from baseline at Week 12
Measured: 12 weeks
Change in waist circumference in centimetre
Change in waist circumference from baseline at Week 12 .
Measured: 12 weeks
RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)
Analysis of AUC0-last
Measured: 12 weeks
RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)
Analysis of AUC0-inf
Measured: 12 weeks
RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)
Analysis of Cmax
Measured: 12 weeks
RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)
Analysis of Tmax
Measured: 12 weeks
RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)
Analysis of t1/2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start8 Mar 2024
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regor Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277934
- Sponsor's protocol ID
- RGT001-075-203
- Status last verified
- Aug 2025
- First submitted
- 1 Feb 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities
- ClinicalTrials.gov ID
- NCT06277934
- Acronym / sponsor ID
- RGT001-075-203
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Regor Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 26 Feb 2024 (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 main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGT001-075 Group | Experimental | Drug: RGT001-075Patients will receive once daily dose of study drug for a total of 12 weeks |
| Placebo Group | Placebo comparator | Drug: PlaceboPatients will receive once daily dose of matching placebo for a total of 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 and ≤ 75 years
- Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
- Have had a stable body weight for the 3 months prior to randomization
Key exclusion criteria (7 listed)
- Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
- Have a prior or planned surgical treatment for obesity
- Have or plan to have endoscopic and/or device-based therapy for obesity
- Have any prior diagnosis of diabetes
- Have an electrocardiogram (ECG) with abnormalities
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 |
|---|---|---|
| RGT001-075Administered orally | Drug | RGT001-075 Group |
| PlaceboAdministered orally | Drug | Placebo Group |
Primary outcome
Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings
Time frame: 14 weeks
10 secondary outcomes
Percent change in body weight
Time frame: 12 weeks
Change in body weight in kilogram
Time frame: 12 weeks
Percentage of participants who achieve ≥5% and ≥10% body weight reduction
Time frame: 12 weeks
Change in Body mass index (BMI) in kg/m^2
Time frame: 12 weeks
Change in waist circumference in centimetre
Time frame: 12 weeks
RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)
Time frame: 12 weeks
RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)
Time frame: 12 weeks
RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)
Time frame: 12 weeks
RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)
Time frame: 12 weeks
RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)
Time frame: 12 weeks
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 7 Aug 2025.
- 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.
10 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 RGT001-075 in people with Obesity, run by Regor Pharmaceuticals Inc. at 10 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 3 inclusion and 7 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings (time frame: 14 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 Aug 2025.