Non-DiabeticPhase 1NCT07212868
The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
A Phase 1 study testing Exogenous glucagon versus saline infusion in people with Non-Diabetic, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Diabetic
- What is being tested?
- Exogenous glucagon versus saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Feb 2026to 30 Jun 2030
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
Mooney A Mark-Johnson, RN
Marzieh Salehi, MD MS
- Recruiting
University of Texas San Antonio
San Antonio, Texas, 78229
Mooney Mark-Johnson, BSN, 210 450 8696, markjohnson@uthscsa.edu
Noelle M Vinson, BSN, 210 567 6707, vinsonn@uthscsa.edu
About this study
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 monoclonal antibody (an antibody made by cloning a unique white blood cell) that blocks the effect of glucagon.
Read the 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 (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
- Non-Diabetic
- Being tested
- REMD-477 versus Placebo, Exogenous glucagon versus saline infusion
- Keywords
- glucagon, glucose metabolism, bariatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMD-477 versus PlaceboDrug
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 infusionOther
The effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied.
| Study group | Role | What they receive |
|---|---|---|
| Mixed Meal study with and without glucagon receptor antagonist | Experimental | Mixed meal test conducted with a sequential design of receiving a single dose subcutaneous injection of glucagon receptor antagonist or placebo. Receives: Drug: REMD-477 versus Placebo |
| Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion | Other | A cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies Receives: Other: Exogenous glucagon versus saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response to meal ingestion
Changes in glucose response to meal ingestion occurred by administration of glucagon receptor antagonist (GRA).
Measured: 0 to 240 minutes
Endogenous glucose production (EGP) during clamp studies
Changes in EGP (measured by tracer technique) with and without glucagon infusion
Measured: 0 to 240 minutes
Secondary outcomes (3)
Prandial glucose kinetics
Glucose flux with and without GRA administration
Measured: Baseline to 240 minutes
Plasma GLP-1, GIP, insulin and glucagon concentrations
Changes in these outcomes following meal ingestion with and without GRA administration
Measured: 0 to 240 minutes
Glucose clearance and insulin and glucagon concentrations during clamp studies
Outcomes with and without glucagon infusion
Measured: 0 to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start25 Feb 2026
- Primary completion1 May 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-DiabeticStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Placebo controlled physiologic study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marzieh Salehi, The University of Texas Health Science Center at San Antonio
- Investigators
- Marzieh Salehi, MD, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212868
- Sponsor's protocol ID
- STUDY00001597
- Other IDs
- R01DK141843
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data summary results will be published in ClinicalTrials.gov as required by law and research findings will be published in a peer reviewed scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Glucagon in Glucose Metabolism in Humans With and Without Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07212868
- Acronym / sponsor ID
- STUDY00001597
- Conditions
- Non-Diabetic
- Keywords
- glucagon, glucose metabolism, bariatric surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 8 Oct 2025 (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.
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 monoclonal antibody (an antibody made by cloning a unique white blood cell) that blocks the effect of glucagon.
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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Placebo controlled physiologic study
| Arm | Type | Receives |
|---|---|---|
| Mixed Meal study with and without glucagon receptor antagonist | Experimental | Drug: REMD-477 versus PlaceboMixed meal test conducted with a sequential design of receiving a single dose subcutaneous injection of glucagon receptor antagonist or placebo. |
| Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion | Other | Other: Exogenous glucagon versus saline infusionA cross-over study to compare the effect of glucagon infusion on glucose metabolism measured during clamp studies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- Diabetes
- Pregnancy/lactation
- Hgb <11
- Current GI obstruction or chronic diarrhea
- Subjects who are not within the age range of 18- 65 years.
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 |
|---|---|---|
| REMD-477 versus PlaceboPlacebo versus glucagon receptor antagonist using a human monoclonal antibody with a high level of antagonistic effect against human glucagon receptor. | Drug | Mixed Meal study with and without glucagon receptor antagonist |
| Exogenous glucagon versus saline infusionThe effect of increased glucagon concentrations in plasma on glucose metabolism during glucose clamp will be studied. | Other | Pancreatic clamp (hypoglycemia and hyperglycemic) with and without glucagon infusion |
Primary outcome
Glycemic response to meal ingestion
Time frame: 0 to 240 minutes
Changes in glucose response to meal ingestion occurred by administration of glucagon receptor antagonist (GRA).
Endogenous glucose production (EGP) during clamp studies
Time frame: 0 to 240 minutes
Changes in EGP (measured by tracer technique) with and without glucagon infusion
3 secondary outcomes
Prandial glucose kinetics
Time frame: Baseline to 240 minutes
Plasma GLP-1, GIP, insulin and glucagon concentrations
Time frame: 0 to 240 minutes
Glucose clearance and insulin and glucagon concentrations during clamp studies
Time frame: 0 to 240 minutes
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 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data summary results will be published in ClinicalTrials.gov as required by law and research findings will be published in a peer reviewed scientific journal.
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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.
Marzieh Salehi, MD, MS principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exogenous glucagon versus saline infusion in people with Non-Diabetic, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Marzieh Salehi, MD, MS (210-450-8560, salehi@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic response to meal ingestion (time frame: 0 to 240 minutes). 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 5 Oct 2026.