ALV-100 for safety and body effects in overweight or obese adults with or without type 2 diabetes

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALV-100 in Participants With Overweight or Obesity With or Without Type 2 Diabetes

This study will test ALV-100 to see if it is safe and how it acts in adults who are overweight or obese, including people with type 2 diabetes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Alveus Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07399678 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, interventional study comparing ALV-100 to placebo in adults aged 18–65 with BMI 27.0–39.9 kg/m2, with or without type 2 diabetes. Participants who meet screening criteria and reproductive status requirements will receive ALV-100 or placebo and undergo close monitoring for safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) measures. The protocol requires stable body weight in the prior 90 days and includes both male and female participants with specific contraception or sterility criteria. The trial is sponsored by Alveus Therapeutics and conducted at Clinical Pharmacology of Miami.

Who should consider this trial

Good fit: Adults 18–65 years old with BMI 27.0–39.9 kg/m2 and stable weight, including people with or without type 2 diabetes, who meet the study's reproductive and contraception criteria are ideal candidates.

Not a fit: People under 18 or over 65, those with BMI outside 27.0–39.9 kg/m2, pregnant or breastfeeding individuals, or those with unstable weight or excluded medical conditions are unlikely to be eligible or to receive benefit from this study.

Why it matters

Potential benefit: If successful, ALV-100 could offer a new treatment option to help reduce weight or improve metabolic control in overweight or obese adults, including those with type 2 diabetes.

How similar studies have performed: While other drug classes for weight loss have shown clinical benefit, ALV-100 is a novel agent at an early Phase 1 stage and has limited prior human data.

Eligibility criteria

Inclusion Criteria:

For Part A and B

* Adult male and female participants, aged 18 to 65 years, inclusive, at the time of signing the informed consent form
* Body mass index between 27.0 to 39.9 kg/m2 at Screening, both inclusive; overweight should be due to excess adipose tissue, as judged by the Investigator.
* Have a stable body weight (\< 5.0 kg/11 lbs self-reported change) within 90 days prior to Screening
* Females must be surgically sterile (by means of bilateral salpingectomy, hysterectomy or bilateral oophorectomy) or be post-menopausal (defined as spontaneous cessation of menses for at least 1 year prior to Screening). Females who are post-menopausal and \< 55 years must have a follicle-stimulating hormone level \> 40 IU/L at Screening.
* Males with female partners of child-bearing potential must be willing to practice abstinence or must agree to use condom as contraception throughout the duration of the study. This criterion may be waived for male participants who have had a documented successful vasectomy \> 6 months before signing the ICF.

For Part B only

* Diagnosis of Type 2 Diabetes for at least 180 days prior to Screening.
* Glycemic control managed by diet and exercise alone or by stable treatment with metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT-2i), with no dose changes within 3 months prior to Screening.
* Hemoglobin A1c (HbA1c) between 7.0 % and 9.0% (equivalent to 53-75 mmol/mol), both inclusive, at Screening.

Exclusion Criteria:

For Part A and B

* History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however mild dyslipidemia, defined as screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below 300 mg/dL (3.39 mmol/L) is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with type 2 diabetes in Part B) at the discretion of the Investigator.
* Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.
* Current or history of chronic or acute pancreatitis.
* Obesity caused by known endocrinologic disorders (e.g., Cushing syndrome) or monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).
* History of major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or anxiety disorder).
* Lifetime history of a suicide attempt or of any suicidal behavior by endorsement of (answered yes to) any of the items in the suicidal behavior section on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
* Systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg at Screening.
* History of or current cardiovascular disease, including but not limited to stable and unstable angina, myocardial infarction, congestive heart failure, transient ischemic attack, stroke, clinically significant arrhythmias and conduction disorders or venous thromboembolism.

Part A only

• History or clinical evidence of Type 1 or Type 2 diabetes mellitus, including HbA1c ≥ 6.5% and/or a fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) at Screening (female participants with a history of gestational diabetes are allowed).

Part B only

* Fasting plasma glucose (FPG) \> 270 mg/dL (15.0 mmol/L) at Screening.
* Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (within1.5 years from Screening) ophthalmologic examination.
* Severe neuropathy as judged by the investigator.
* Advanced nephropathy (defined as albuminuria ≥ 300 mg/g).
* History of severe hypoglycemia or hypoglycemic unawareness as judged by the investigator.

Where this trial is running

Miami, Florida

• Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Study Director

Conditions Overweight or Obese Adults; Overweight or Obese, Type 2 Diabetes; Overweight, Obese, Obesity, Type 2 Diabetes, Weight loss