ALV-100 for Obesity

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alveus Therapeutics, Inc.

Must be taking: Metformin, SGLT-2 inhibitors

Disqualifiers: Cardiovascular disease, Pancreatitis, Psychiatric disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes

Who Is on the Research Team?

Karen Tornøe, MD, PhD

Principal Investigator

Alveus Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a BMI of 27.0 to 39.9, stable weight in the last 90 days, and HbA1c levels between 7.0% and 9.0%. Women must be post-menopausal or surgically sterile; men should use contraception if their partners can bear children. For part B only: participants need a Type 2 Diabetes diagnosis managed by diet/exercise or stable metformin/SGLT-2i treatment.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes for at least 6 months.

My HbA1c level is between 7.0% and 9.0%.

I am eligible for both Part A and B of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending doses of ALV-100 or placebo by subcutaneous injection

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ALV-100

Trial Overview

The study tests ALV-100's safety, tolerability, and how it affects the body (PK/PD) in overweight/obese individuals with or without Type 2 Diabetes (T2D). Participants will either receive ALV-100 or a placebo to compare effects.

How Is the Trial Designed?

Group I: Part B - T2D Cohort (ALV-100) Experimental Treatment 1 Intervention

Participants with overweight or obesity with type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Group II: Part A - Cohort 4 (ALV-100) Experimental Treatment 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Group III: Part A - Cohort 3 (ALV-100) Experimental Treatment 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Group IV: Part A - Cohort 2 (ALV-100) Experimental Treatment 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Group V: Part A - Cohort 1 (ALV-100) Experimental Treatment 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.

Group VI: Part A - Cohort 1 (Placebo) Placebo Group 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Group VII: Part A - Cohort 2 (Placebo) Placebo Group 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Group VIII: Part A - Cohort 3 (Placebo) Placebo Group 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Group IX: Part A - Cohort 4 (Placebo) Placebo Group 1 Intervention

Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.

Group X: Part B - T2D Cohort (Placebo) Placebo Group 1 Intervention

Participants with overweight or obesity with type 2 diabetes will receive placebo by subcutaneous injection.

Who Is Running the Clinical Trial?

Alveus Therapeutics, Inc.

Lead Sponsor