Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D

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

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

Study Overview

• Status: Recruiting
• Conditions: Overweight or Obese Adults; Overweight or Obese, Type 2 Diabetes
• Intervention / Treatment: Drug: ALV-100; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: +1 215-607-2243; Email: clinicaltrials@alveustx.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33172
      • Recruiting
      • Clinical Pharmacology of Miami
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Ohio Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A - Cohort 1 (ALV-100); Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.	Drug: ALV-100; Participants will receive multiple ascending doses of ALV-100.
Placebo Comparator: Part A - Cohort 1 (Placebo); Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.	Drug: Placebo; Participants will receive placebo matching ALV-100, volume-matched to active dose.
Experimental: Part A - Cohort 2 (ALV-100); Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.	Drug: ALV-100; Participants will receive multiple ascending doses of ALV-100.
Placebo Comparator: Part A - Cohort 2 (Placebo); Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.	Drug: Placebo; Participants will receive placebo matching ALV-100, volume-matched to active dose.
Experimental: Part A - Cohort 3 (ALV-100); Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.	Drug: ALV-100; Participants will receive multiple ascending doses of ALV-100.
Placebo Comparator: Part A - Cohort 3 (Placebo); Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.	Drug: Placebo; Participants will receive placebo matching ALV-100, volume-matched to active dose.
Experimental: Part A - Cohort 4 (ALV-100); Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.	Drug: ALV-100; Participants will receive multiple ascending doses of ALV-100.
Placebo Comparator: Part A - Cohort 4 (Placebo); Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.	Drug: Placebo; Participants will receive placebo matching ALV-100, volume-matched to active dose.
Experimental: Part B - T2D Cohort (ALV-100); Participants with overweight or obesity with type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.	Drug: ALV-100; Participants will receive multiple ascending doses of ALV-100.
Placebo Comparator: Part B - T2D Cohort (Placebo); Participants with overweight or obesity with type 2 diabetes will receive placebo by subcutaneous injection.	Drug: Placebo; Participants will receive placebo matching ALV-100, volume-matched to active dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Incidence of treatment emergent adverse events (TEAEs)	From First Dose to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - Cmax, MD	Maximum observed serum concentration after multiple doses (MD) (Cmax, MD)	From First Dose to Week 52
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - AUC(0-τ), MD	Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC(0-τ), MD)	From First Dose to Week 52
Pharmacodynamic (PD) impact on body weight	Change from baseline in body weight	Baseline, Week 32 and Week 52
Pharmacodynamic (PD) impact on body weight percentage	Change from baseline in body weight percentage	Baseline, Week 32 and Week 52
Immunogenicity	Incidence of Anti-ALV-100 drug antibodies, including assessments of cross-reactivity and neutralizing antibodies.	From Baseline to Week 52
Relationship between ALV-100 serum concentration and QTc interval changes (Part A Only)	Measurement of change in individual specific heart rate corrected QT interval (QTcI) and Fridericia heart rate corrected QT interval (QTcF) on 12-lead ECG.	From First Dose to Week 52
Paracetamol (acetaminophen) absorption test (PAT) (Part A Only)	Measurement of acetaminophen PK parameters to evaluate the effect of ALV-100 on the gastric emptying rate.	From First Dose to Week 52
Pharmacodynamic (PD) impact of ALV-100 on antidiabetic medication (Part B Only)	Change in use of concomitant glucose-lowering medication	From Baseline to Week 32
Pharmacodynamic (PD) impact of ALV-100 on glycemic parameters (Part B Only)	Measuring the number of participants achieving target Hemoglobin A1c values	Week 32 and Week 52
Hypoglycemic Safety (Part B Only)	Measured by the incidence of symptomatic hypoglycemia, documented symptomatic hypoglycemia and severe hypoglycemia	From Baseline to Week 52

Collaborators and Investigators

• Sponsor: Alveus Therapeutics, Inc.
• Investigators: Study Director: Karen Tornøe, MD, PhD, Alveus Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Overweight, Obese, Obesity, Type 2 Diabetes, Weight loss
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Body Weight Changes; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ALV-102-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No