Recruiting
Phase 1

REMD-477

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07212868

Conditions

Non-Diabetic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

REMD-477 versus Placebo

Exogenous glucagon versus saline infusion

Study Details

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 monoclonal antibody (an antibody made by cloning a unique white blood cell) that blocks the effect of glucagon.

Conditions

Non-Diabetic

Study ID

NCT07212868

Start date

Feb 25, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

May 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form from participant.
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:

1. Diabetes
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)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

other: 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

Interventions

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.

Primary outcome measure

  • Glycemc response to meal ingestion [ Time Frame: 0 to 240 minutes ]
  • Endogenous glucose production (EGP) during clamp studies [ Time Frame: 0 to 240 minutes ]

Central Contacts and Locations

Central contacts

Marzieh Salehi, MD, MS

210-450-8560davism13@uthscsa.edu

Andrea Hansis-Diarte, MPh

210-567-3208hansisdiarte@uthscsa.edu

Locations

Texas Diabetes Institute - University Health System

Recruiting

San Antonio, Texas, United States, 78207

Principal Investigator:

Marzieh Salehi, MD MS

University of Texas San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Matthew A Davis

davism13@uthscsa.edu

Mooney Mark-Johnson

markjohnson@uthscsa.edu

Principal Investigator:

Marzieh Salehi, MD, MS

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • glucagon
  • glucose metabolism
  • bariatric surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-05-11.