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NCT05912621 · ClinicalTrials.gov registry record · Phase 2
Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity
A Phase 2 study of Obesity and Overweight, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT05912621: Recruiting Phase 2 study of Obesity and Overweight, sponsored by Stanford University.
NCT05912621 is a Phase 2 study of Obesity and Overweight that is actively recruiting participants, run by Stanford University. The registered enrollment target is 66 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05912621, a Phase 2 study of Obesity and Overweight, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity, affecting 40% of US adults and costing 173b annually, represents a significant health care burden (1). It is associated with increased risk for multiple chronic diseases including hypertension, type 2 diabetes (T2D), cardiovascular disease, and NAFLD, as well as cancer, osteoarthritis, and obstructive sleep apnea. The investigators plan to test the hypothesis that tirzepatide, a dual GLP/GIP agonist, improves metabolic health (insulin resistance and regional fat distribution and cardiovascular risk profile) not only by inducing weight loss via GLP1-agonism, but also via beneficial cellular and molecular changes in adipose tissue, given that GIP binds receptors in human fat cells. Based on studies in mice showing that GIP alone or tirzepitide treatment decreases inflammation, increases lipid buffering (fat storage in the fat cells instead of releasing it into the bloodstream), and improves glucose homeostasis. The investigators believe that the GIP component of tirzepatide will make fat cells healthier and reverse lipotoxicity, which is one of the mechanisms by which obesity leads to insulin resistance, disordered regional fat distribution, and type 2 diabetes. To date, the effect of dual GLP1 and GIP agonist treatment on adipose tissue has not been evaluated in humans. Given the existing but limited data, dual GIP/GLP-1 agonist treatment in obese humans with metabolic risk factors is an attractive pharmacologic candidate that would lead to both weight loss and healthier fat, potentially offering uniquely powerful synergistic clinical benefits. It is thus of tremendous importance to define the biological effects of dual-agonist treatment on human adipose tissue structure and function, as well as related improvements in regional fat distribution and systemic adipose and muscle insulin sensitivity. In this study, the investigators will randomize overweight (with risk factors) or obese nondiabetic individuals to hypocaloric diet or tirzepatide for 22 weeks with
Primary Outcome
Using a multisizer, we will identify the size and distribution changes of fat cells from baseline to the end of the weight loss period to compare between tirzepatide administration and dietary restriction group
Conditions Studied
Interventions
- DRUG Tirzepatide
Study Locations (1)
California
- Clinical and Translational Research Unit - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-11-09 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What NCT05912621 shows while recruiting
NCT05912621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Tirzepatide is the first listed.
NCT05912621 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05912621 about?
NCT05912621 is a clinical study titled "Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity". Obesity, affecting 40% of US adults and costing 173b annually, represents a significant health care burden (1). It is associated with increased risk for multiple chronic diseases including hypertension, type 2 diabetes (T2D), cardiovascular disease, and NAFLD, as well as cancer, osteoarthritis, and ...
What is the current status of trial NCT05912621?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2023-11-09. Estimated completion is 2029-12.
What conditions does trial NCT05912621 study?
This clinical trial studies the following conditions: Obesity, Overweight, Overweight and Obesity.
What interventions are being tested in trial NCT05912621?
The interventions under investigation include: Tirzepatide (DRUG).
Who is sponsoring clinical trial NCT05912621?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05912621 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05912621's enrollment target sits among peer trials
66 616th of 1053 higher than 433 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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