The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
NCT ID: NCT07212868
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2025-12-01
2030-06-30
Brief Summary
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Detailed Description
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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 (Continuous glucose monitoring). Participants will also have a blood draw for liver enzymes8 weeks after the administration of REMD 477.
Participants will spend up to 3- 6 months participating in any pair study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
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Mixed 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.
Pancreatic 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.
Interventions
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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.
Exogenous glucagon versus saline infusion
The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.
Eligibility Criteria
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Inclusion Criteria
2. Male or female, ≤65 and ≥18 years old
3. 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
4. HbA1c ≤6%
5. Willing to adhere to the study intervention regimen
6. Female subjects of childbearing potential must have a negative pregnancy test at screening and all the study visits, and must not be lactating
7. 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.
Exclusion Criteria
2. Pregnancy/lactation
3. Hgb \<11
4. Current GI obstruction or chronic diarrhea
5. Subjects who are not within the age range of 18- 65 years.
6. Evidence of active cardiorespiratory, hepatic, gastrointestinal or renal disease.
7. History of allergy to the administered drugs.
8. 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.
9. Substance dependence or history of alcohol abuse and/or excess alcohol intake
10. Patients on ketogenic diet
11. Prisoners or institutionalized individuals
12. AST (SGOT) \> 3 times upper limit of normal
13. ALT (SGPT) \> 3 times upper limit of normal
14. History of clinical hypoglycemia documents based on Whipples' triad (ONLY for Aim 2)
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Marzieh Salehi
Professor
Principal Investigators
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Marzieh Salehi, MD, MS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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Texas Diabetes Institute - University Health System
San Antonio, Texas, United States
University of Texas San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Marzieh Salehi, MD, MS
Role: primary
Other Identifiers
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STUDY00001597
Identifier Type: -
Identifier Source: org_study_id