NIDDMPhase 4NCT05949008
Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
A Phase 4 study testing Metformin Extended Release (ER) Oral Tablet in people with NIDDM and Obesity, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Metformin Extended Release (ER) Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 30 Jul 2028
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 18 years at the time of signing informed consent.
- Body Mass Index (BMI) ≥ 27 kg/m2
- Waist circumference >40" for men, and >35" for women
Who cannot join
- A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- Diagnosed with T2D (HbA1c >7.5 (53 mmol/mol)
- Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents.
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 mL/min/1.73 m2 (< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening
- History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable).
- History or lactic acidosis
Show all 14Show fewer
- Liver problems
- Congestive heart failure
- History of alcoholism
- Recent surgery
- Heart attack, severe infection or stroke
- Any unstable medical conditions or terminal diagnosis
- Pregnancy or lactation
- Allergy and intolerance to metformin
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90024
About this study
Official title: Effect of Metformin ER With Hypocaloric Diet on Weight Loss in Overweight/Obese Patients With Increased Waist Circumference
Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.
Read the detailed description
Obesity is a growing epidemic in the United States. Weight gain is associated with an increased risk of developing life-threatening conditions such as high blood pressure or diabetes. Therefore, there is great interest in developing non-invasive treatments to help combat obesity. Currently, there are only few weight-loss drugs available for the treatment of obesity. In the more recent past, GLP-1 analogues (a type of non-insulin medication used to treat patients with diabetes) are being promoted as a new strategy to lose weight without major side effects however, with high costs and challenging supply chain issues.
This is a double-blinded, randomized study. This means that participants will be assigned to one of two groups. Participants will have a 1:1 chance of being assigned to receive either the study drug or a placebo (a capsule that does not contain the active ingredients). This assignment will be determined by chance. The process is similar to drawing cards or picking straws. This means your assignment to one of the groups is based on chance and not a medical decision made by the study doctor. In addition, neither participants nor the investigators will know what groups participants have been assigned to.
During this study, your participation will last up to 26 weeks (including screen) with a total of 8 clinic visits. Participants will undergo a total of 5 blood draws, blood samples will be taken at screen baseline and weeks 8, 16 and 24.
- Being tested
- Metformin Extended Release (ER) Oral Tablet, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Extended Release (ER) Oral TabletDrug
Metformin ER will be provided as 1000 mg capsules by Qingdao Baheal Pharmaceutical Co., Ltd. In addition to the active ingredient metformin HCl,each tablet contains the following inactive ingredients: Povidone, Sodium Lauryl Sulfate, Magnesium Stearate, Cellulose Acetate, Polyethylene Glycol (PEG 400, PEG 8000), Triacetin, Hypromellose, Titanium Dioxide, Polysorbate 80, Ferrosoferric Oxide, Shellac.
PlaceboDrug
Matching placebo will be provided as 1000 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Metformin Extended Release (ER) Oral Tablets | Experimental | This is a 24-week, randomized, double-blinded, two arm parallel clinical trial comparing metformin ER vs. placebo in combination with a hypocaloric diet (-500 kcal/day). 150 individuals with obesity and increased waist circumference will be randomized to taking metformin ER with hypocaloric diet or placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day. Receives: Drug: Metformin Extended Release (ER) Oral Tablet |
| Placebo | Placebo comparator | Patients in the placebo arm will be randomized to placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who achieve body weight reduction ≥5% from baseline
Percent change in body weight reduction ≥5% from baseline (week 0) to week 24.
Measured: 24 Weeks
Change in total body weight from baseline
Percent change in total body weight (TBW) from baseline (week 0) to week 24 in body weight.
Measured: 24 Weeks
Secondary outcomes (11)
Change in total Body Mass Index (BMI) from baseline
Change from baseline (week 0) to week 24 in: BMI
Measured: 24 Weeks
Percent change in body composition from baseline
Change from baseline (week 0) to week 24 - Body composition will be measured using a bioelectrical impedance analysis (BIA) scale. Measurements will include fat mass (kg), lean mass (kg), and body fat percentage. Data will be summarized as mean change from baseline to study endpoint for each group.
Measured: 24 weeks
Change in waist circumference from baseline
Change from baseline (week 0) to week 24 in:Waist circumference (cm)
Measured: 24 weeks
Change in insulin sensitivity from baseline
Insulin sensitivity will be assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels. QUICKI (Quantitative Insulin Sensitivity Check Index) will be calculated using fasting glucose and insulin. The outcome will be reported as the change in QUICKI from baseline to Week 24.
Measured: 24 Weeks
Change in fasting blood lipids from baseline
Change from baseline (week 0) to week 24 in Fasting blood lipids
Measured: 24 Weeks
Change in vascular function parameters (blood pressure and pulse wave velocity)
Vascular function will be assessed through two parameters:
Systolic and diastolic blood pressure (mmHg)
Pulse wave velocity (m/s) Each variable will be reported as a change from baseline to Week 24.
Measured: 24 weeks
Change in inflammatory markers from baseline
Measured: 24 weeks
Change in daily dietary intake (calories and macronutrients)
Daily energy and macronutrient intake will be assessed using 3-day food records. The outcome includes:
Total energy intake (kcal/day) Carbohydrate intake (g/day) Protein intake (g/day) Fat intake (g/day) Each variable will be reported as a change from baseline to Week 24.
Measured: 24 weeks
Change in physical activity levels from baseline
Physical activity will be tracked using MyFitnessPal, which syncs data from wearable devices and user-logged exercise sessions. The following variables will be assessed:
Average daily step count (steps/day) Weekly exercise duration (minutes/week), including structured physical activity Exercise frequency (days/week)
Measured: 24 weeks
Change in quality of life from baseline
● SF-36 QOL questionnaire
Measured: 24 weeks
Change in glycemic control
Glycemic control will be assessed by measuring fasting glucose (mg/dL), fasting insulin (µIU/mL), and glycated hemoglobin A1c (reported as % and mmol/mol). All three measures will be obtained at baseline and Week 24. Each parameter will be reported as a change from baseline.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start22 Nov 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NIDDMStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to placebo or Metformin.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijaya Surampudi MD, University of California, Los Angeles
- Investigators
- Vijiya Surampudi, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949008
- Sponsor's protocol ID
- 22-001670
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2023
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin ER With Hypocaloric Diet on Weight Loss in Overweight/Obese Patients With Increased Waist Circumference
- ClinicalTrials.gov ID
- NCT05949008
- Acronym / sponsor ID
- 22-001670
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 17 Jul 2023 (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.
Metformin is a drug used to treat patients with diabetes. The aim of this study is to examine the effect of Metformin along with a low-calorie diet on obese and/or overweight adults with an increased waist measurement. In addition, the study also aims to look at the effect of the drug vs. placebo on quality of life and physical activity.
Detailed description
Obesity is a growing epidemic in the United States. Weight gain is associated with an increased risk of developing life-threatening conditions such as high blood pressure or diabetes. Therefore, there is great interest in developing non-invasive treatments to help combat obesity. Currently, there are only few weight-loss drugs available for the treatment of obesity. In the more recent past, GLP-1 analogues (a type of non-insulin medication used to treat patients with diabetes) are being promoted as a new strategy to lose weight without major side effects however, with high costs and challenging supply chain issues.
This is a double-blinded, randomized study. This means that participants will be assigned to one of two groups. Participants will have a 1:1 chance of being assigned to receive either the study drug or a placebo (a capsule that does not contain the active ingredients). This assignment will be determined by chance. The process is similar to drawing cards or picking straws. This means your assignment to one of the groups is based on chance and not a medical decision made by the study doctor. In addition, neither participants nor the investigators will know what groups participants have been assigned to.
During this study, your participation will last up to 26 weeks (including screen) with a total of 8 clinic visits. Participants will undergo a total of 5 blood draws, blood samples will be taken at screen baseline and weeks 8, 16 and 24.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, single-blind, controlled trial. All eligible participants will be randomly assigned to placebo or Metformin.
| Arm | Type | Receives |
|---|---|---|
| Metformin Extended Release (ER) Oral Tablets | Experimental | Drug: Metformin Extended Release (ER) Oral TabletThis is a 24-week, randomized, double-blinded, two arm parallel clinical trial comparing metformin ER vs. placebo in combination with a hypocaloric diet (-500 kcal/day). 150 individuals with obesity and increased waist circumference will be randomized to taking metformin ER with hypocaloric diet or placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in the placebo arm will be randomized to placebo with hypocaloric diet. All patients will receive dietary and exercise counseling with the intent of reducing their average caloric intake by 500 kcal/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age ≥ 18 years at the time of signing informed consent.
- Body Mass Index (BMI) ≥ 27 kg/m2
- Waist circumference >40" for men, and >35" for women
Key exclusion criteria (14 listed)
- A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- Diagnosed with T2D (HbA1c >7.5 (53 mmol/mol)
- Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents.
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 mL/min/1.73 m2 (< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening
- History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable).
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 |
|---|---|---|
| Metformin Extended Release (ER) Oral TabletMetformin ER will be provided as 1000 mg capsules by Qingdao Baheal Pharmaceutical Co., Ltd. In addition to the active ingredient metformin HCl,each tablet contains the following inactive ingredients: Povidone, Sodium Lauryl Sulfate, Magnesium Stearate, Cellulose Acetate, Polyethylene Glycol (PEG 400, PEG 8000), Triacetin, Hypromellose, Titanium Dioxide, Polysorbate 80, Ferrosoferric Oxide, Shellac. | Drug | Metformin Extended Release (ER) Oral Tablets |
| PlaceboMatching placebo will be provided as 1000 mg capsules | Drug | Placebo |
Primary outcome
Number of participants who achieve body weight reduction ≥5% from baseline
Time frame: 24 Weeks
Percent change in body weight reduction ≥5% from baseline (week 0) to week 24.
Change in total body weight from baseline
Time frame: 24 Weeks
Percent change in total body weight (TBW) from baseline (week 0) to week 24 in body weight.
11 secondary outcomes
Change in total Body Mass Index (BMI) from baseline
Time frame: 24 Weeks
Percent change in body composition from baseline
Time frame: 24 weeks
Change in waist circumference from baseline
Time frame: 24 weeks
Change in insulin sensitivity from baseline
Time frame: 24 Weeks
Change in fasting blood lipids from baseline
Time frame: 24 Weeks
Change in vascular function parameters (blood pressure and pulse wave velocity)
Time frame: 24 weeks
Change in inflammatory markers from baseline
Time frame: 24 weeks
Change in daily dietary intake (calories and macronutrients)
Time frame: 24 weeks
Change in physical activity levels from baseline
Time frame: 24 weeks
Change in quality of life from baseline
Time frame: 24 weeks
Change in glycemic control
Time frame: 24 weeks
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 8 Jun 2026.
- 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.
Vijiya Surampudi, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Extended Release (ER) Oral Tablet in people with NIDDM and Obesity, run by University of California, Los Angeles 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 3 inclusion and 14 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 8 Jun 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of participants who achieve body weight reduction ≥5% from baseline (time frame: 24 Weeks). The study lists 2 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 8 Jun 2026.