Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus
Recruiting · 21 sites across 10 states
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Study care at no cost to you
For your time and travel
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 18 or older at the time of signing.
- •Have type 2 diabetes diagnosed at least 180 days before screening.
- •Have HbA1c between 7.0% and 10.5% (inclusive) at screening.
- •Have a stable BMI of at least 27 kg/m2 for at least 90 days before screening.
- •Are able to do study-required blood sugar checks (fasting blood draw and 7-point SMBG for 3 days) and follow visit instructions. (SMBG means self-monitored blood glucose using the study-provided glucometer.)
🚫 You may not be able to join if…
- •Have type 1 diabetes.
- •Had more than 5% body-weight change in the 90 days before screening (based on self-report, regardless of records).
- •Had pancreatitis (acute or chronic) or had more than 3 low-blood-sugar episodes (blood glucose <70 mg/dL / 3.9 mmol/L) in the 90 days before screening.
- •Have chronic kidney disease with an estimated glomerular filtration rate (eGFR) under 60.
- •Have poorly controlled high blood pressure (systolic >160 mmHg and/or diastolic >100 mmHg) or poorly controlled hypothyroidism (TSH >6 mIU/L or <0.4 mIU/L).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–any age
- ✓A BMI around 27 or higher
- ✓Have Obesity / overweight or Type 2 diabetes
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure, Kidney disease, Depression
- !Not for people who are pregnant or breastfeeding
- !May require a break from current GLP-1 medications
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study 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.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+
Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07282743 · Locations: Arkansas · Florida · Kansas · Oklahoma · Andhra Pradesh · Karnataka · Kerala · Maharashtra · National Capital Territory of Delhi · Tamil Nadu