Type 2 Diabetes MellitusPhase 2NCT05297045
A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes
A Phase 2 study testing RGT001-075 in people with Type 2 Diabetes Mellitus, run by Regor Pharmaceuticals Inc. at 1 site in United States.
Trial summary
This is a phase 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2022to 30 May 2023
- 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
- Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening
- Screening HbA1c 7.0-10.5%
- Male or female, age 18-75 years
- Screening BMI 24.5 - 40 kg/m2
- Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential
Who cannot join
- Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor [DPP-4i], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy
- Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening
- Has any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening
- Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- Has active proliferative diabetic retinopathy or macular edema
- Has a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid cancer
Show all 10Show fewer
- Has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for <5 years prior to screening
- Has evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
- Has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening
- Has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Oral RGT001-075 in Adult Patients With Uncontrollable Type 2 Diabetes Mellitus on Metformin Therapy
This is a phase 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control with diet and exercise and stable metformin treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- RGT001-075, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGT001-075Drug
Oral GLP1 Receptor Agonist
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Dose Group A | Experimental | Not described Receives: Drug: RGT001-075 |
| Dose Group B | Experimental | Not described Receives: Drug: RGT001-075 |
| Dose Group C | Experimental | Not described Receives: Drug: RGT001-075 |
| Dose Group D | Experimental | Not described Receives: Drug: RGT001-075 |
| Dose Group E | Experimental | Not described Receives: Drug: RGT001-075 |
| Dose Group F | Experimental | Not described Receives: Drug: RGT001-075 |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population
Measured: up to 16 weeks
Secondary outcomes (37)
Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population
Measured: up to 16 weeks
Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population
Measured: up to 16 weeks
Change in body mass index from baseline to end of treatment in the modified intent-to-treat population
Measured: up to 16 weeks
Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population
Measured: up to 16 weeks
Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population
Measured: up to 16 weeks
Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%
Measured: up to 16 weeks
Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss
Measured: up to 16 weeks
Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation
Measured: up to 16 weeks
Vital signs - Systolic blood pressure (mmHg) absolute change from baseline
Measured: up to 16 weeks
Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline
Measured: up to 16 weeks
Vital signs - Heart rate (beats/minute) absolute change from baseline
Measured: up to 16 weeks
Vital signs - Body weight (kg) absolute and percent change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - complete blood count absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum sodium absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum potassium absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum total bilirubin absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum direct bilirubin absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum creatinine absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum uric acid absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum calcium absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum lipase absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum amylase absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - eGFR (calculated) absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - fasting serum glucose absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum albumin absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum total protein absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline
Measured: up to 16 weeks
Safety clinical laboratories - serum calcitonin absolute change from screening
Measured: up to 16 weeks
ECG interval change from baseline absolute and categorical outliers >450ms
Measured: up to 16 weeks
Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start29 Mar 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Why it stopped: Terminated due to financial constraint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 17 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
- NCT05297045
- Sponsor's protocol ID
- RGT001-075_01-201
- Status last verified
- Nov 2023
- First submitted
- 24 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Oral RGT001-075 in Adult Patients With Uncontrollable Type 2 Diabetes Mellitus on Metformin Therapy
- ClinicalTrials.gov ID
- NCT05297045
- Acronym / sponsor ID
- RGT001-075_01-201
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to financial constraint.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Regor Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 25 Mar 2022 (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 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control with diet and exercise and stable metformin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose Group A | Experimental | Drug: RGT001-075 |
| Dose Group B | Experimental | Drug: RGT001-075 |
| Dose Group C | Experimental | Drug: RGT001-075 |
| Dose Group D | Experimental | Drug: RGT001-075 |
| Dose Group E | Experimental | Drug: RGT001-075 |
| Dose Group F | Experimental | Drug: RGT001-075 |
| Placebo Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening
- Screening HbA1c 7.0-10.5%
- Male or female, age 18-75 years
- Screening BMI 24.5 - 40 kg/m2
- Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential
Key exclusion criteria (10 listed)
- Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor [DPP-4i], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy
- Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening
- Has any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening
- Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- Has active proliferative diabetic retinopathy or macular edema
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 |
|---|---|---|
| RGT001-075Oral GLP1 Receptor Agonist | Drug | Dose Group A, Dose Group B, Dose Group C, Dose Group D, Dose Group E, Dose Group F |
| PlaceboPlacebo comparator | Other | Placebo Group |
Primary outcome
Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population
Time frame: up to 16 weeks
37 secondary outcomes
Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population
Time frame: up to 16 weeks
Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population
Time frame: up to 16 weeks
Change in body mass index from baseline to end of treatment in the modified intent-to-treat population
Time frame: up to 16 weeks
Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population
Time frame: up to 16 weeks
Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population
Time frame: up to 16 weeks
Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%
Time frame: up to 16 weeks
Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss
Time frame: up to 16 weeks
Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation
Time frame: up to 16 weeks
Vital signs - Systolic blood pressure (mmHg) absolute change from baseline
Time frame: up to 16 weeks
Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline
Time frame: up to 16 weeks
Vital signs - Heart rate (beats/minute) absolute change from baseline
Time frame: up to 16 weeks
Vital signs - Body weight (kg) absolute and percent change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - complete blood count absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum sodium absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum potassium absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum total bilirubin absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum direct bilirubin absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum creatinine absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum uric acid absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum calcium absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum lipase absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum amylase absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - eGFR (calculated) absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - fasting serum glucose absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum albumin absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum total protein absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline
Time frame: up to 16 weeks
Safety clinical laboratories - serum calcitonin absolute change from screening
Time frame: up to 16 weeks
ECG interval change from baseline absolute and categorical outliers >450ms
Time frame: up to 16 weeks
Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events
Time frame: up to 16 weeks
Results and safety
The study was stopped early (reason given: Terminated due to financial constraint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
1 site 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 Type 2 Diabetes Mellitus, run by Regor Pharmaceuticals Inc. at 1 site 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 10 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Terminated due to financial constraint.). 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?
Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population (time frame: up to 16 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 18 Nov 2023.