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Tests treatment safety and results for Type II Diabetes Mellitus
Official title Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
ClinicalTrials.gov ID: NCT07282743
What this study is testing
What is GL0034 Dose Level 1?
GL0034 Dose Level 1 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for type ii diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant is willing and able to sign a written ICF or e-ICF.
- Men or women ≥18 years of age at the time of signing ICF or e-ICF.
- Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.
- Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.
- Participant has a stable BMI ≥27 kg/m2 for at least 90 days prior to screening.
You likely can't join if
- Participants who have a history of type I diabetes mellitus.
- A self-reported change in \>5% of body weight within 90 days before screening irrespective of medical records.
- History of pancreatitis (acute or chronic) or \>3 hypoglycemic episodes (blood glucose level \<70 mg/dL or 3.9 mmol/L) within 90 days prior to...
- Diagnosis of chronic kidney disease with estimated glomerular filtration rate \<60.
- Poorly controlled hypertension with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg.
- Poorly controlled hypothyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L.
See the full eligibility criteria
Who can join
- Participant is willing and able to sign a written ICF or e-ICF.
- Men or women ≥18 years of age at the time of signing ICF or e-ICF.
- Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.
- Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.
- Participant has a stable BMI ≥27 kg/m2 for at least 90 days prior to screening.
- Participant is able and willing to undergo fasting blood draw (i.e. at least 8 hours after last eating or drinking) as well as 7-point SMBG check for 3 consecutive days prior to designated scheduled visits by using a...
- Participant on stable daily doses of metformin for at least 90 days prior to screening.
- Participant who are on metformin and not the following agents for at least 3 months prior to screening: DPP-4 inhibitors, alpha-glucosidase enzyme inhibitors, sulfonylureas, sodium-glucose transport 2 inhibitors, amylin...
- If participant is a woman of childbearing potential (WOCP)\ , she must agree to use a highly effective method of contraception during the study in conjunction with a barrier method of contraception, and continue the...
- Male participants with female partners of child-bearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy) during the study. In addition, male participants...
- If participant is a WOCP, she must have a negative serum pregnancy test (SPT) at Screening and a negative urine pregnancy at baseline, with results available before IP administration.
- Participant is willing and able to comply with the study protocol, visit schedule, and other study-related instructions and procedures.
- Participant is willing and able to independently record the response on various scales and make entries using the e-Patient reported outcomes (ePRO) device.
What rules you out
- Participants who have a history of type I diabetes mellitus.
- A self-reported change in \>5% of body weight within 90 days before screening irrespective of medical records.
- History of pancreatitis (acute or chronic) or \>3 hypoglycemic episodes (blood glucose level \<70 mg/dL or 3.9 mmol/L) within 90 days prior to screening.
- Diagnosis of chronic kidney disease with estimated glomerular filtration rate \<60.
- Poorly controlled hypertension with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg.
- Poorly controlled hypothyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L.
- Diabetes mellitus and/or obesity that is induced by endocrine disorders (e.g. Cushing Syndrome) or medication use (e.g. corticosteroids) as judged by the Investigator.
- Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed \>1 year before screening is allowed). Previous or planned (during the trial period) obesity treatment with surgery or a weight loss...
- History of major depressive disorder within 2 years before randomization.
- History of other severe psychiatric illnesses (i.e. schizophrenia, bipolar disorder).
- Any lifetime history of a suicidal attempt.
- Participants with any medical condition [i.e. gastroparesis, uncontrolled gastroesophageal reflux disease, or diarrhea with or without a diagnosis of a diagnosis of irritable bowel syndrome] that, in the opinion of the...
- Participant had a myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to IP administration.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, sudden cardiac death, unexplained death, long QT syndrome, or death from a primary dysrhythmia potentially...
- Surgery scheduled for the trial duration period, except for very minor surgical procedures in the opinion of the Investigator.
- Participants with active malignancy. Note: participants with past history of malignancy may be included if:
- Participant has history of basal cell or in-situ squamous cell carcinoma of skin that has been adequately treated and resolved, per Investigator's judgement.
- Participant has history of other malignancy that have been adequately treated with no evidence of recurrence/relapse within the last 5 years, per Investigator's judgement.
- Presence of diabetic retinopathy [both nonproliferative diabetic retinopathy and proliferative diabetic retinopathy]) or maculopathy in either eye that was verified by a fundoscopic examination within 90 days prior to...
- Known moderate to severe coronary, carotid, or peripheral vascular disease that has planned or will likely need revascularization during the study.
- Participants with any other condition, which in the opinion of the Investigator, precludes participation in the study (either poses an unacceptable risk to the participant or interferes with assessment/interpretation of...
- Known hypersensitivity to the study IP or its excipients.
- History of alcohol or drug abuse in the previous two years (Alcohol abuse in this study is defined as \>14 standard drinks per week in men or \>7 standard drinks per week in women ± a history of alcohol withdrawal...
- Participants are taking, or will start, medications with narrow therapeutic index such as digoxin, warfarin, etc, or those that will prolong QTc interval.
- Participants received any medications for the treatment of type II diabetes mellitus other than those stated in the inclusion criteria within 90 days before screening. Short-term insulin treatment for a maximum of 7...
- Participants who have used medications in the family of GLP-1 agonists in the past.
- Treatment with any herbal diet supplements, over-the-counter diet medications as an attempt to lose weight within 90 days before screening.
- Treatment with orlistat, lorcaserin, zonisamide, topiramate, phentermine, buproprion, or naltrexone that could promote weight loss within 90 days before screening.
- Participation in any organized or online weight-reduction program (i.e. Weight Watchers) within 90 days before screening.
- Screening calcitonin ≥50 ng/L (pg/mL).
- Participants having clinically significant abnormal values on Screening laboratory tests or other evidence of uncontrolled disease involving any system-organ (e.g., cardiovascular, pulmonary, renal, hepatic...
- Participants with positive urine drug screen [amphetamine, barbiturate, benzodiazepine, cocaine, opiates] with substances that are not part of participant's routine medical care. Tetrahydrocannabinols is acceptable for...
- Participants have clinically significant ECG abnormality , including QTcF \>450 msec for males and \>470 msec for females, or at high risk for arrhythmia such as judged by the Investigator conditions listed in Criteria...
- Pregnant or lactating females.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Hialeah Gardens, Florida, United States
- Lakeland, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- El Dorado, Kansas, United States
- Newton, Kansas, United States
- Oklahoma City, Oklahoma, United States
- Guntur, Andhra Pradesh, India
- Bangalore, Karnataka, India
- Kozhikode, Kerala, India
- Trivandrum, Kerala, India
- Kolhāpur, Maharashtra, India
- Mumbai, Maharashtra, India
- Pune, Maharashtra, India
- New Delhi, National Capital Territory of Delhi, India
- Chennai, Tamil Nadu, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Hialeah Gardens, Florida, United States; Lakeland, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States; El Dorado, Kansas, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.