AzTrials
AzTrials

ObesityPhase 2NCT05885074

Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors

A Phase 2 study testing Empagliflozin Arm, Exercise capacity VO2 maximum determination and Exercise Challenge in people with Obesity and Weight Loss, run by University of Alabama at Birmingham at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Weight Loss
What is being tested?
Empagliflozin Arm, Exercise capacity VO2 maximum determination and Exercise Challenge
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
30 Jan 2025to 30 Jun 2027
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age more than or equal to 18 years
  • Body mass index more than or equal to 30 kg/m2 who have lost ≥5% of body weight within the past 6 months without taking any pharmacotherapy for weight loss

Who cannot join

  • Age less than 18 years at screening.
  • Untreated systolic BP <100 or >160 mmHg at baseline, or diastolic BP <80 or >100 mmHg at baseline
  • Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence)
  • Taking pharmacotherapy indicated for weight loss, such as GLP-1 agonists or with weight loss as an adverse event
  • History of Type I Diabetes
  • History of lung disease
Show all 15Show fewer
  • Have any past or present illness of cardiovascular disease, including myocardial infarction, angina, cardiac arrhythmia, diabetes, stroke, TIA, or seizure
  • Current or past (<12 months) history of smoking
  • Estimated glomerular filtration rate (GFR) < 60 ml/min/1.73 m2 (CKD-EPI equation) urine albumin creatinine ratio ≥30 mg/g
  • Hepatic Transaminase (AST and ALT) levels >3x the upper limit of normal
  • Significant psychiatric illness
  • Anemia (men, Hct < 38%; women, Hct <36%)
  • Inability to exercise on a treadmill
  • Consumption of more than 2 alcoholic drinks daily
  • Any contraindications to empagliflozin

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (REE), which may be a probable mechanism for this lack of WLM. Most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in REE which prevents WLM. Therefore, techniques that increase REE may promote WLM in these individuals. Pre-clinical studies for Empagliflozin - Sodium-glucose Cotransporter-2 (SGLT2) inhibitor have shown an increase in REE. Thus, in addition to reducing the cardiovascular risk, SGLT2 inhibitor may promote WLM by increasing REE. This study aims to promote WLM in obese individuals by increasing the REE using SGLT2 inhibitor therapy.

Conditions
Obesity, Weight Loss
Being tested
Empagliflozin Arm, Control Arm, Exercise capacity VO2 maximum determination, Exercise Challenge
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin ArmDrug

    The subject will be randomized, in a double-blind manner to Empagliflozin 25mg once daily for a period of 12 months

  • Control ArmOther

    The subject will be randomized, in a double-blind manner to receive placebo once daily for a period of 12 months

  • Exercise capacity VO2 maximum determinationOther

    Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol and will also undergo a DEXA scan to determine the body mass.

  • Exercise ChallengeOther

    Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill and will also undergo a resting energy expenditure test.

Study groups in NCT05885074
Study groupRoleWhat they receive
Empagliflozin ArmExperimentalInvestigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take empagliflozin 25mg/day orally for 12 months.
Receives: Drug: Empagliflozin Arm; Other: Exercise capacity VO2 maximum determination; Other: Exercise Challenge
Placebo ArmPlacebo comparatorInvestigator will enroll 12 obese participants who have intentionally lost greater than or equal to 5% of body weight through a non-pharmacological structured weight loss program based on diet and exercise within the last 6 months. The participants will take a placebo pill orally once a day for 12 months.
Receives: Other: Control Arm; Other: Exercise capacity VO2 maximum determination; Other: Exercise Challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Resting Energy Expenditure

    Change in Resting Energy Expenditure between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

Secondary outcomes (15)

  1. Change in Body Weight

    Change in Body Weight between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  2. Change in Body Mass Index

    Change in Body Mass Index between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  3. Change in Waist Circumference

    Change in Waist Circumference between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  4. Change in HbA1C levels

    Change in HbA1C levels between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  5. Change in lipid profile

    Change in Lipid profile between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  6. Change in HOMA-IR

    Change in HOMA-IR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  7. Change in ESR

    Change in ESR between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  8. Change in CRP

    Change in CRP between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  9. Change in IL-6

    Change in IL-6 between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  10. Change in TNF-α

    Change in TNF-α between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  11. Change in glucagon-like peptide-1 (GLP-1)

    Change in glucagon-like peptide-1 (GLP-1) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  12. Change in peptide YY (PYY)

    Change in peptide YY (PYY) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  13. Change in ghrelin

    Change in ghrelin between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  14. Change in glucose-dependent insulinotropic polypeptide (GIP)

    Change in glucose-dependent insulinotropic polypeptide (GIP) between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

  15. Change in glucagon

    Change in glucagon between the two arms (Empagliflozin v/s Placebo) from baseline and after 12 months of intervention

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start30 Jan 2025 (estimated)
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Why it stopped: Funding

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05885074
Sponsor's protocol ID
300011125
Status last verified
Aug 2024
First submitted
11 May 2023
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Empagliflozin Arm, Exercise capacity VO2 maximum determination and Exercise Challenge in people with Obesity and Weight Loss, run by University of Alabama at Birmingham 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 2 inclusion and 15 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: withdrawn, as of the sponsor's last update on 7 Aug 2024. 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 withdrawn before enrolling participants, so there are no results.

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 Resting Energy Expenditure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05885074.

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 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in