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Clinical Trial NCT07212868 for Non-Diabetic is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery Phase 1 150 Monoclonal Antibody
Clinical Trial NCT07212868 is designed to study Other for Non-Diabetic. It is a Phase 1 interventional study that is recruiting, having started on February 25, 2026, with plans to enroll 150 participants. Led by The University of Texas Health Science Center at San Antonio, it is expected to complete by June 30, 2030. The latest data from ClinicalTrials.gov was last updated on March 12, 2026.
Brief Summary
The goal of this study is to understand the role of glucagon signal on glucose metabolism in individuals with and without bariatric surgery. The study is involved with measuring glucose metabolism with glucagon infusion and glucagon receptor blockade. We use an investigational drug called REMD 477. "Investigational" means that the has not yet been approved by the U.S. Food & Drug Administration (FDA). REMD-477 is a ...Show More
Detailed Description
Participants will be screened, and if eligible will be enrolled for metabolic studies for two separate aims. In aim 1, they undergo glucose clamp study with and without glucagon infusion.
In aim 2, they undergo 2-day meal studies with and without a single dose administration of investigational drug, REMD 477 using a small needle subcutaneously. During these studies glycemic profile will be evaluated using CGM (Conti...
Show MoreOfficial Title
The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
Conditions
Non-DiabeticOther Study IDs
- STUDY00001597
- R01DK141843 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2026-02-25
Last Update Posted
2026-03-12
Completion Date (Estimated)
2030-06-30
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
glucagon
glucose metabolism
bariatric surgery
glucose metabolism
bariatric surgery
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMixed Meal study with and without glucagon receptor antagonist Mixed meal test conducted with a sequential design of receiving a single dose subcutaneous injection of glucagon receptor antagonist or placebo. | REMD-477 versus Placebo Placebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor. |
OtherPancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion A cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies | Exogenous glucagon versus saline infusion The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Glycemc response to meal ingestion | Changes in glucose response to meal ingestion occurred by administration of glucagon receptor antagonist (GRA). | 0 to 240 minutes |
Endogenous glucose production (EGP) during clamp studies | Changes in EGP (measured by tracer technique) with and without glucagon infusion | 0 to 240 minutes |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Prandial glucose kinetics | Glucose flux with and without GRA administration | Baseline to 240 minutes |
Plasma GLP-1, GIP, insulin and glucagon concentrations | Changes in these outcomes following meal ingestion with and without GRA administration | 0 to 240 minutes |
Glucose clearance and insulin and glucagon concentrations during clamp studies | Outcomes with and without glucagon infusion | 0 to 240 minutes |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Provision of signed and dated informed consent form from participant.
- Male or female, ≤65 and ≥18 years old
- Subjects with history of gastric bypass surgery and sleeve gastrectomy more than a year since surgery and non-surgical subjects without history of gastrointestinal (GI) surgery
- HbA1c ≤6%
- Willing to adhere to the study intervention regimen
- Female subjects of childbearing potential must have a negative pregnancy test at screening and all the study visits, and must not be lactating
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions during the study.It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
- Diabetes
- Pregnancy/lactation
- Hgb <11
- Current GI obstruction or chronic diarrhea
- Subjects who are not within the age range of 18- 65 years.
- Evidence of active cardiorespiratory, hepatic, gastrointestinal or renal disease.
- History of allergy to the administered drugs.
- History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures.
- Substance dependence or history of alcohol abuse and/or excess alcohol intake
- Patients on ketogenic diet
- Prisoners or institutionalized individuals
- AST (SGOT) > 3 times upper limit of normal
- ALT (SGPT) > 3 times upper limit of normal
- History of clinical hypoglycemia documents based on Whipples' triad (ONLY for Aim 2)
The University of Texas Health Science Center at San AntonioNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Study Responsible Party
Marzieh Salehi, Principal Investigator, Professor, The University of Texas Health Science Center at San Antonio
Study Central Contact
Contact: Marzieh Salehi, MD, MS, 210-450-8560, [email protected]
Contact: Andrea Hansis-Diarte, MPh, 210-567-3208, [email protected]
2 Study Locations in 1 Countries
Texas
Texas Diabetes Institute - University Health System, San Antonio, Texas, 78207, United States
Matthew A Davis, Contact, [email protected]
Mooney Mark-Johnson, Contact, [email protected]
Marzieh Salehi, MD MS, Principal Investigator
Recruiting
University of Texas San Antonio, San Antonio, Texas, 78229, United States
Matthew A Davis, Contact, [email protected]
Mooney Mark-Johnson, Contact, [email protected]
Marzieh Salehi, MD, MS, Principal Investigator
Recruiting